Trial Outcomes & Findings for The Budesonide in Babies (BiB) Trial (NCT NCT04545866)
NCT ID: NCT04545866
Last Updated: 2025-11-10
Results Overview
A composite outcome for infants who were diagnosed with physiologic BPD or died by 36 weeks PMA. Physiologic BPD is determined using existing NRN GDB criteria at 36 weeks' PMA. Infants alive an in hospital are classified based on respiratory status at 36 week's PMA or by a room air weaning challenge performed between 36 and 37 weeks' PMA. Infants who are transferred or discharged before 36 weeks are classified based on the support they are receiving at that time. Infants who died before 36 weeks' PMA are not assessed for BPD. Deaths include all-cause deaths between randomization and 36 weeks' PMA.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
642 participants
Primary outcome timeframe
Randomization to 36 weeks PMA
Results posted on
2025-11-10
Participant Flow
One infant was randomized and treated in error after the parent/guardian declined consent. The infant was withdrawn from the trial upon discovery of the protocol violation. At the parent's request, the infant's data have been fully redacted. No data are available for reporting or analysis (including treatment allocation), and this participant is excluded from the intention to treat (ITT) population.
Participant milestones
| Measure |
Budesonide + Surfactant
Budesonide (Pulmicort nebulizing suspension) 1 ml/kg + Surfactant (poractant alfa; Curosurf) 2.5 ml/kg
|
Surfactant Alone
Surfactant (poractant alfa; Curosurf) 2.5 ml/kg
|
|---|---|---|
|
Overall Study
STARTED
|
323
|
318
|
|
Overall Study
COMPLETED
|
321
|
318
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Budesonide + Surfactant
Budesonide (Pulmicort nebulizing suspension) 1 ml/kg + Surfactant (poractant alfa; Curosurf) 2.5 ml/kg
|
Surfactant Alone
Surfactant (poractant alfa; Curosurf) 2.5 ml/kg
|
|---|---|---|
|
Overall Study
Withdrawal by Parent(s)/Legal Guardian(s)
|
1
|
0
|
|
Overall Study
Withdrawal by Physician
|
1
|
0
|
Baseline Characteristics
The Budesonide in Babies (BiB) Trial
Baseline characteristics by cohort
| Measure |
BUDE
n=323 Participants
Budesonide (Pulmicort nebulizing suspension) 1 ml/kg + Surfactant (poractant alfa; Curosurf) 2.5 ml/kg
|
SURF
n=318 Participants
Surfactant (poractant alfa; Curosurf) 2.5 ml/kg
|
Total
n=641 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.8 weeks
STANDARD_DEVIATION 1.9 • n=5 Participants
|
25.9 weeks
STANDARD_DEVIATION 2 • n=20 Participants
|
25.9 weeks
STANDARD_DEVIATION 1.9 • n=40 Participants
|
|
Age, Customized
Greater Than or Equal to 26 0/7 weeks
|
185 Participants
n=5 Participants
|
188 Participants
n=20 Participants
|
373 Participants
n=40 Participants
|
|
Age, Customized
Less Than 26 0/7 weeks
|
138 Participants
n=5 Participants
|
130 Participants
n=20 Participants
|
268 Participants
n=40 Participants
|
|
Sex/Gender, Customized
Female
|
163 Participants
n=5 Participants
|
156 Participants
n=20 Participants
|
319 Participants
n=40 Participants
|
|
Sex/Gender, Customized
Male
|
158 Participants
n=5 Participants
|
162 Participants
n=20 Participants
|
320 Participants
n=40 Participants
|
|
Sex/Gender, Customized
Missing
|
2 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Black or African America
|
101 Participants
n=5 Participants
|
122 Participants
n=20 Participants
|
223 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Other
|
21 Participants
n=5 Participants
|
17 Participants
n=20 Participants
|
38 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
19 Participants
n=5 Participants
|
10 Participants
n=20 Participants
|
29 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White
|
183 Participants
n=5 Participants
|
168 Participants
n=20 Participants
|
351 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
50 Participants
n=5 Participants
|
54 Participants
n=20 Participants
|
104 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
254 Participants
n=5 Participants
|
254 Participants
n=20 Participants
|
508 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Randomization to 36 weeks PMAPopulation: An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.
A composite outcome for infants who were diagnosed with physiologic BPD or died by 36 weeks PMA. Physiologic BPD is determined using existing NRN GDB criteria at 36 weeks' PMA. Infants alive an in hospital are classified based on respiratory status at 36 week's PMA or by a room air weaning challenge performed between 36 and 37 weeks' PMA. Infants who are transferred or discharged before 36 weeks are classified based on the support they are receiving at that time. Infants who died before 36 weeks' PMA are not assessed for BPD. Deaths include all-cause deaths between randomization and 36 weeks' PMA.
Outcome measures
| Measure |
BUDE
n=323 Participants
Budesonide (Pulmicort nebulizing suspension) 1 ml/kg + Surfactant (poractant alfa; Curosurf) 2.5 ml/kg
|
SURF
n=318 Participants
Surfactant (poractant alfa; Curosurf) 2.5 ml/kg
|
|---|---|---|
|
Physiologic BPD or Death by 36 Weeks PMA
No
|
101 Participants
|
102 Participants
|
|
Physiologic BPD or Death by 36 Weeks PMA
Unknown
|
2 Participants
|
0 Participants
|
|
Physiologic BPD or Death by 36 Weeks PMA
Yes
|
220 Participants
|
216 Participants
|
SECONDARY outcome
Timeframe: Randomization to 36 weeks PMAPopulation: An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.
Died (all-cause) after randomization and by 36 weeks PMA
Outcome measures
| Measure |
BUDE
n=323 Participants
Budesonide (Pulmicort nebulizing suspension) 1 ml/kg + Surfactant (poractant alfa; Curosurf) 2.5 ml/kg
|
SURF
n=318 Participants
Surfactant (poractant alfa; Curosurf) 2.5 ml/kg
|
|---|---|---|
|
Death by 36 Weeks PMA
No
|
272 Participants
|
276 Participants
|
|
Death by 36 Weeks PMA
Unknown
|
2 Participants
|
0 Participants
|
|
Death by 36 Weeks PMA
Yes
|
49 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: At 36 weeks PMAPopulation: An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.
Diagnosed with physiologic BPD at 36 weeks PMA. Physiologic BPD is determined using existing NRN GDB criteria at 36 weeks' PMA. Infants alive an in hospital are classified based on respiratory status at 36 week's PMA or by a room air weaning challenge performed between 36 and 37 weeks' PMA. Infants who are transferred or discharged before 36 weeks are classified based on the support they are receiving at that time. Infants who died before 36 weeks' PMA are not assessed for BPD.
Outcome measures
| Measure |
BUDE
n=323 Participants
Budesonide (Pulmicort nebulizing suspension) 1 ml/kg + Surfactant (poractant alfa; Curosurf) 2.5 ml/kg
|
SURF
n=318 Participants
Surfactant (poractant alfa; Curosurf) 2.5 ml/kg
|
|---|---|---|
|
Physiologic BPD
Unknown
|
51 Participants
|
42 Participants
|
|
Physiologic BPD
Yes
|
171 Participants
|
174 Participants
|
|
Physiologic BPD
No
|
101 Participants
|
102 Participants
|
SECONDARY outcome
Timeframe: At 36 weeks PMAPopulation: An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.
BPD Severity Grade at 36 weeks PMA according to the Jensen et al. (2019; PMID: 30995069) definition, also known as pragmatic BPD. Infants are assess based on the mode of support at 36 weeks' postmenstrual age regardless of prior duration or current level of oxygen therapy.
Outcome measures
| Measure |
BUDE
n=323 Participants
Budesonide (Pulmicort nebulizing suspension) 1 ml/kg + Surfactant (poractant alfa; Curosurf) 2.5 ml/kg
|
SURF
n=318 Participants
Surfactant (poractant alfa; Curosurf) 2.5 ml/kg
|
|---|---|---|
|
Grade of BPD Severity
Unknown
|
54 Participants
|
48 Participants
|
|
Grade of BPD Severity
Grade 0 (No BPD)
|
70 Participants
|
66 Participants
|
|
Grade of BPD Severity
Grade 1 (Mild BPD)
|
72 Participants
|
78 Participants
|
|
Grade of BPD Severity
Grade 2 (Moderate BPD)
|
99 Participants
|
100 Participants
|
|
Grade of BPD Severity
Grade 3 (Severe BPD)
|
28 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: At 36 weeks PMAPopulation: An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.
Diagnosed with Severe (Grade 3) BPD at 36 weeks PMA according to the Jensen et al. (2019; PMID: 30995069) definition. This outcome is a dichotomy of the pragmatic BPD severity grades (Grade 3 vs. Grade 2, 1, or 0).
Outcome measures
| Measure |
BUDE
n=323 Participants
Budesonide (Pulmicort nebulizing suspension) 1 ml/kg + Surfactant (poractant alfa; Curosurf) 2.5 ml/kg
|
SURF
n=318 Participants
Surfactant (poractant alfa; Curosurf) 2.5 ml/kg
|
|---|---|---|
|
Severe BPD
No
|
241 Participants
|
244 Participants
|
|
Severe BPD
Unknown
|
54 Participants
|
48 Participants
|
|
Severe BPD
Yes
|
28 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 7 days post last dose of study drug through 36 weeks PMAPopulation: An intent-to-treat (ITT) analysis which included all infants participants who were randomized and who provided outcome data.
Use of any postnatal steroids for treatment of evolving chronic lung disease (separate from study drug) between 7 days after the final dose of study drug and 36 weeks PMA. Note: Infants were permitted up to two doses of study drug within 50 hours postnatal age, so this outcome spans 7-10 days postnatal age through 36 weeks postmenstrual age.
Outcome measures
| Measure |
BUDE
n=323 Participants
Budesonide (Pulmicort nebulizing suspension) 1 ml/kg + Surfactant (poractant alfa; Curosurf) 2.5 ml/kg
|
SURF
n=318 Participants
Surfactant (poractant alfa; Curosurf) 2.5 ml/kg
|
|---|---|---|
|
Use of Additional Postnatal Steroids
No
|
216 Participants
|
202 Participants
|
|
Use of Additional Postnatal Steroids
Yes
|
102 Participants
|
109 Participants
|
|
Use of Additional Postnatal Steroids
Unknown
|
5 Participants
|
7 Participants
|
Adverse Events
BUDE
Serious events: 63 serious events
Other events: 232 other events
Deaths: 49 deaths
SURF
Serious events: 55 serious events
Other events: 187 other events
Deaths: 42 deaths
Serious adverse events
| Measure |
BUDE
n=323 participants at risk
Budesonide (Pulmicort nebulizing suspension) 1 ml/kg + Surfactant (poractant alfa; Curosurf) 2.5 ml/kg
|
SURF
n=318 participants at risk
Surfactant (poractant alfa; Curosurf) 2.5 ml/kg
|
|---|---|---|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/323 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.31%
1/318 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Cardiac disorders
Cardio-respiratory arrest neonatal
|
0.00%
0/323 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.31%
1/318 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Congenital, familial and genetic disorders
Newborn persistent pulmonary hypertension
|
0.31%
1/323 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.31%
1/318 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Congenital, familial and genetic disorders
Pulmonary hypoplasia
|
0.31%
1/323 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.63%
2/318 • Number of events 2 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.31%
1/323 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.00%
0/318 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Gastrointestinal disorders
Intestinal perforation
|
4.3%
14/323 • Number of events 14 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
1.9%
6/318 • Number of events 6 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/323 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.31%
1/318 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Gastrointestinal disorders
Necrotising colitis
|
0.31%
1/323 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.00%
0/318 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Gastrointestinal disorders
Neonatal intestinal perforation
|
0.00%
0/323 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
1.3%
4/318 • Number of events 4 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.31%
1/323 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.31%
1/318 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Infections and infestations
Sepsis
|
1.9%
6/323 • Number of events 6 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.63%
2/318 • Number of events 2 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Infections and infestations
Sepsis neonatal
|
0.62%
2/323 • Number of events 2 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.63%
2/318 • Number of events 2 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Infections and infestations
Septic shock
|
0.31%
1/323 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.00%
0/318 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
0.31%
1/323 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.00%
0/318 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.5%
8/323 • Number of events 8 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.94%
3/318 • Number of events 3 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.31%
1/323 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.31%
1/318 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Nervous system disorders
Haemorrhage intracranial
|
4.6%
15/323 • Number of events 15 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
5.3%
17/318 • Number of events 17 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.31%
1/323 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.00%
0/318 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Nervous system disorders
Intraventricular haemorrhage neonatal
|
0.00%
0/323 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.31%
1/318 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Product Issues
Device occlusion
|
0.00%
0/323 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.31%
1/318 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.31%
1/323 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.63%
2/318 • Number of events 2 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal asphyxia
|
0.00%
0/323 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.31%
1/318 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal pneumothorax
|
0.00%
0/323 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.31%
1/318 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress syndrome
|
0.93%
3/323 • Number of events 3 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.94%
3/318 • Number of events 3 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.62%
2/323 • Number of events 2 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
1.9%
6/318 • Number of events 6 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary air leakage
|
0.93%
3/323 • Number of events 3 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
1.6%
5/318 • Number of events 5 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
2.5%
8/323 • Number of events 8 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
2.5%
8/318 • Number of events 8 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.62%
2/323 • Number of events 2 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.00%
0/318 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertensive crisis
|
0.00%
0/323 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.31%
1/318 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.62%
2/323 • Number of events 2 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.63%
2/318 • Number of events 2 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Vascular disorders
Hypertension
|
0.00%
0/323 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.31%
1/318 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Vascular disorders
Hypotension
|
4.0%
13/323 • Number of events 14 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
2.2%
7/318 • Number of events 7 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
Other adverse events
| Measure |
BUDE
n=323 participants at risk
Budesonide (Pulmicort nebulizing suspension) 1 ml/kg + Surfactant (poractant alfa; Curosurf) 2.5 ml/kg
|
SURF
n=318 participants at risk
Surfactant (poractant alfa; Curosurf) 2.5 ml/kg
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/323 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.31%
1/318 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.31%
1/323 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.00%
0/318 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.31%
1/323 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.00%
0/318 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Congenital, familial and genetic disorders
Newborn persistent pulmonary hypertension
|
0.00%
0/323 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.31%
1/318 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
0.00%
0/323 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.31%
1/318 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.62%
2/323 • Number of events 2 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.00%
0/318 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.31%
1/323 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.00%
0/318 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Gastrointestinal disorders
Necrotising colitis
|
0.31%
1/323 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.00%
0/318 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Gastrointestinal disorders
Necrotising enterocolitis neonatal
|
0.00%
0/323 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.31%
1/318 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/323 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.31%
1/318 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Infections and infestations
Meningitis
|
0.00%
0/323 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.31%
1/318 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Infections and infestations
Sepsis
|
1.9%
6/323 • Number of events 6 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
1.6%
5/318 • Number of events 5 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Infections and infestations
Sepsis neonatal
|
1.5%
5/323 • Number of events 5 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.94%
3/318 • Number of events 3 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
0.31%
1/323 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.00%
0/318 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.31%
1/323 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.00%
0/318 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.00%
0/323 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.31%
1/318 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
64.4%
208/323 • Number of events 263 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
48.4%
154/318 • Number of events 191 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.62%
2/323 • Number of events 2 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.00%
0/318 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/323 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.31%
1/318 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Nervous system disorders
Haemorrhage intracranial
|
6.2%
20/323 • Number of events 20 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
5.3%
17/318 • Number of events 17 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Nervous system disorders
Intraventricular haemorrhage neonatal
|
0.93%
3/323 • Number of events 3 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.31%
1/318 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Nervous system disorders
Periventricular leukomalacia
|
1.5%
5/323 • Number of events 5 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.63%
2/318 • Number of events 2 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Product Issues
Device occlusion
|
0.31%
1/323 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.94%
3/318 • Number of events 3 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Renal and urinary disorders
Oliguria
|
0.31%
1/323 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.00%
0/318 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.31%
1/323 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.00%
0/318 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.31%
1/323 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.31%
1/318 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.5%
5/323 • Number of events 5 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.63%
2/318 • Number of events 2 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary air leakage
|
1.2%
4/323 • Number of events 4 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
1.6%
5/318 • Number of events 5 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.93%
3/323 • Number of events 3 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
1.6%
5/318 • Number of events 5 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage neonatal
|
0.00%
0/323 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.31%
1/318 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/323 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.63%
2/318 • Number of events 2 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary interstitial emphysema syndrome
|
0.93%
3/323 • Number of events 3 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
0.31%
1/318 • Number of events 1 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Vascular disorders
Hypertension
|
8.7%
28/323 • Number of events 31 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
6.3%
20/318 • Number of events 22 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
|
Vascular disorders
Hypotension
|
13.0%
42/323 • Number of events 45 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
16.7%
53/318 • Number of events 57 • Adverse events were monitored from treatment through 7 days (168 hours) post-treatment, or treatment through 30 days (720 hours) post-treatment for SIP and PVL. All-cause mortality was monitored from randomization through 36 weeks PMA.
AE onset was monitored from treatment initiation through 7 days after the last dose of study drug (30 days for SIP and PVL). This window includes up to 10 days postnatal age (or 33 days PNA for SIP/PVL). AEs were not monitored for infants who did not initiate treatment. All-cause mortality was monitored from randomization through 36 weeks PMA or prior study status (discharge, transfer). Note: Treatment group is reported as randomized. Published analyses may use treatment as received.
|
Additional Information
Namasivayam Ambalavanan MD
University of Alabama at Birmingham
Phone: 2059344680
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place