Trial Outcomes & Findings for IGF-1/IGFBP3 Prevention of Retinopathy of Prematurity (NCT NCT01096784)
NCT ID: NCT01096784
Last Updated: 2021-06-14
Results Overview
ROP was measured by central exams with fundus photography. Maximum severity of ROP stage across all retinal examinations included International Classification of Retinopathy of Prematurity, a 5 stage system, for the classification of ROP with 7 different outcomes of the ROP stage in each retinal examination: 0, 1, 2, 3, 3+, 4, and 5. This is an ordinal scale with higher numbers indicating a more severe outcome. The maximum severity of ROP across all time points was assessed from 31 PMA weeks up to 40 PMA Weeks +/- 4 days (end of study).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
121 participants
Primary outcome timeframe
End of study
Results posted on
2021-06-14
Participant Flow
The study was conducted in multiple centres in Italy, the Netherlands, Poland, Sweden, the United Kingdom and the United States between 18 Jun 2010 and 30 March 2016.
A total of 121 participants were enrolled and randomized into the study.
Participant milestones
| Measure |
rhIGF-1/rhIGFBP-3
Participants received insulin-like growth factor (rhIGF-I)/insulin-like growth factor binding protein-3 (rhIGFBP-3) 250 microgram per kilogram (mcg/kg) for 24 hours through continuous intravenous (IV) infusion from Day 0 up to 29 weeks 6 days of post-menstrual age (PMA).
|
Standard of Care (Control)
Participants in this control group do not received any treatment other than the standard care.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
60
|
|
Overall Study
COMPLETED
|
46
|
46
|
|
Overall Study
NOT COMPLETED
|
15
|
14
|
Reasons for withdrawal
| Measure |
rhIGF-1/rhIGFBP-3
Participants received insulin-like growth factor (rhIGF-I)/insulin-like growth factor binding protein-3 (rhIGFBP-3) 250 microgram per kilogram (mcg/kg) for 24 hours through continuous intravenous (IV) infusion from Day 0 up to 29 weeks 6 days of post-menstrual age (PMA).
|
Standard of Care (Control)
Participants in this control group do not received any treatment other than the standard care.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Adverse Event
|
11
|
9
|
|
Overall Study
Protocol Deviation
|
2
|
2
|
|
Overall Study
Administrative Decision
|
0
|
1
|
|
Overall Study
Other Unspecified
|
0
|
1
|
Baseline Characteristics
IGF-1/IGFBP3 Prevention of Retinopathy of Prematurity
Baseline characteristics by cohort
| Measure |
rhIGF-1/rhIGFBP-3
n=61 Participants
Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
|
Standard of Care (Control)
n=60 Participants
Participants in this control group do not received any treatment other than the standard care.
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.60 Weeks
STANDARD_DEVIATION 1.207 • n=5 Participants
|
25.62 Weeks
STANDARD_DEVIATION 1.397 • n=7 Participants
|
25.61 Weeks
STANDARD_DEVIATION 1.300 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End of studyPopulation: Full Analysis Set (FAS) included all randomized participants who received the study drug and participants in the control group who received Standard of Care.
ROP was measured by central exams with fundus photography. Maximum severity of ROP stage across all retinal examinations included International Classification of Retinopathy of Prematurity, a 5 stage system, for the classification of ROP with 7 different outcomes of the ROP stage in each retinal examination: 0, 1, 2, 3, 3+, 4, and 5. This is an ordinal scale with higher numbers indicating a more severe outcome. The maximum severity of ROP across all time points was assessed from 31 PMA weeks up to 40 PMA Weeks +/- 4 days (end of study).
Outcome measures
| Measure |
rhIGF-1/rhIGFBP-3
n=61 Participants
Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
|
Standard of Care (Control)
n=60 Participants
Participants in this control group do not received any treatment other than the standard care.
|
|---|---|---|
|
Severity of Retinopathy of Prematurity (ROP) as Compared to the Severity of ROP in an Untreated Control Population
ROP of Stage "0"
|
14 participants
|
24 participants
|
|
Severity of Retinopathy of Prematurity (ROP) as Compared to the Severity of ROP in an Untreated Control Population
ROP of Stage "1"
|
4 participants
|
4 participants
|
|
Severity of Retinopathy of Prematurity (ROP) as Compared to the Severity of ROP in an Untreated Control Population
ROP of Stage "2"
|
17 participants
|
13 participants
|
|
Severity of Retinopathy of Prematurity (ROP) as Compared to the Severity of ROP in an Untreated Control Population
ROP of Stage "3"
|
6 participants
|
3 participants
|
|
Severity of Retinopathy of Prematurity (ROP) as Compared to the Severity of ROP in an Untreated Control Population
ROP of Stage "3+"
|
6 participants
|
6 participants
|
|
Severity of Retinopathy of Prematurity (ROP) as Compared to the Severity of ROP in an Untreated Control Population
ROP of Stage "4"
|
0 participants
|
0 participants
|
|
Severity of Retinopathy of Prematurity (ROP) as Compared to the Severity of ROP in an Untreated Control Population
ROP of Stage "5"
|
0 participants
|
0 participants
|
|
Severity of Retinopathy of Prematurity (ROP) as Compared to the Severity of ROP in an Untreated Control Population
Missing
|
14 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Day 0 to 40 Weeks Post Menstrual Age (EOS)Population: FAS with number of participants evaluable for this outcome.
Outcome measures
| Measure |
rhIGF-1/rhIGFBP-3
n=37 Participants
Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
|
Standard of Care (Control)
n=31 Participants
Participants in this control group do not received any treatment other than the standard care.
|
|---|---|---|
|
Time to Discharge From Neonatal Intensive Care (TDNIC)
|
82.00 Days
Interval 69.0 to 96.0
|
74.00 Days
Interval 69.0 to 93.0
|
SECONDARY outcome
Timeframe: At 36 Weeks Post Menstrual AgePopulation: FAS with participants evaluable for this outcome.
Severity of BPD as mild, moderate and severe were based on the National Institute of Child Health and Human Development (NICHD) guidelines for preterm infants born at gestational age (GA) less than (\<) 32 weeks. Mild: oxygen requirement during the first 28 days but in room air at PMA 36 weeks or discharge to home, whichever comes first. Moderate BPD: oxygen requirement during the first 28 days and oxygen \<30 percent (%) at PMA 36 weeks or discharge to home, whichever comes first. Severe BPD: oxygen requirement during the first 28 days and oxygen greater than equal (≥)30% through head hood or nasal canula, or continuous positive airway pressure, or mechanical ventilation, or high flow nasal cannula ≥2 L/min at PMA 36 weeks or discharge to home, whichever comes first.
Outcome measures
| Measure |
rhIGF-1/rhIGFBP-3
n=47 Participants
Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
|
Standard of Care (Control)
n=49 Participants
Participants in this control group do not received any treatment other than the standard care.
|
|---|---|---|
|
Number of Participants With Bronchopulmonary Dysplasia (BPD)
No BPD
|
4 participants
|
4 participants
|
|
Number of Participants With Bronchopulmonary Dysplasia (BPD)
Mild
|
23 participants
|
16 participants
|
|
Number of Participants With Bronchopulmonary Dysplasia (BPD)
Moderate
|
9 participants
|
5 participants
|
|
Number of Participants With Bronchopulmonary Dysplasia (BPD)
Severe
|
10 participants
|
22 participants
|
|
Number of Participants With Bronchopulmonary Dysplasia (BPD)
Unable to determine
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Day 0 to 40 Weeks Post Menstrual Age (EOS)Population: FAS
The rate of change is the rate of specific body weight change per day in kilogram (kg).
Outcome measures
| Measure |
rhIGF-1/rhIGFBP-3
n=61 Participants
Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
|
Standard of Care (Control)
n=60 Participants
Participants in this control group do not received any treatment other than the standard care.
|
|---|---|---|
|
Rate of Change in Body Weight
|
0.021 kilogram per day (kg/day)
Interval 0.019 to 0.022
|
0.023 kilogram per day (kg/day)
Interval 0.021 to 0.024
|
SECONDARY outcome
Timeframe: Day 0 to 40 Weeks Post Menstrual Age (EOS)Population: FAS
The rate of change is the length change per day in centimeter (cm).
Outcome measures
| Measure |
rhIGF-1/rhIGFBP-3
n=61 Participants
Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
|
Standard of Care (Control)
n=60 Participants
Participants in this control group do not received any treatment other than the standard care.
|
|---|---|---|
|
Rate of Change in Length
|
0.141 centimeter per day (cm/day)
Interval 0.0132 to 0.149
|
0.156 centimeter per day (cm/day)
Interval 0.147 to 0.164
|
SECONDARY outcome
Timeframe: Day 0 to 40 Weeks Post Menstrual Age (EOS)Population: FAS
The rate of change is the head circumference change per day in centimetre (cm).
Outcome measures
| Measure |
rhIGF-1/rhIGFBP-3
n=61 Participants
Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
|
Standard of Care (Control)
n=60 Participants
Participants in this control group do not received any treatment other than the standard care.
|
|---|---|---|
|
Rate of Change in Head Circumference
|
0.115 cm/day
Interval 0.109 to 0.121
|
0.119 cm/day
Interval 0.113 to 0.125
|
SECONDARY outcome
Timeframe: 40 Weeks PMA/ (EOS) +/- 4 daysPopulation: FAS
Brain volume was measured using cerebral magnetic resonance imaging (MRI). Brain volume included cerebrospinal volume, gray matter volume, white matter volume, and total cerebellar volume
Outcome measures
| Measure |
rhIGF-1/rhIGFBP-3
n=61 Participants
Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
|
Standard of Care (Control)
n=60 Participants
Participants in this control group do not received any treatment other than the standard care.
|
|---|---|---|
|
Brain Development Assessed by Brain Volume at 40 Weeks PMA/EOS
White Matter Volume
|
110.23 cubic centimeter
Standard Deviation 25.565
|
117.62 cubic centimeter
Standard Deviation 24.422
|
|
Brain Development Assessed by Brain Volume at 40 Weeks PMA/EOS
Cerebrospinal Fluid Volume
|
87.94 cubic centimeter
Standard Deviation 26.788
|
93.70 cubic centimeter
Standard Deviation 25.540
|
|
Brain Development Assessed by Brain Volume at 40 Weeks PMA/EOS
Gray Matter Volume
|
206.34 cubic centimeter
Standard Deviation 31.797
|
221.98 cubic centimeter
Standard Deviation 33.827
|
|
Brain Development Assessed by Brain Volume at 40 Weeks PMA/EOS
Total Cerebellar Volume
|
18.27 cubic centimeter
Standard Deviation 5.302
|
19.20 cubic centimeter
Standard Deviation 4.854
|
SECONDARY outcome
Timeframe: Day 0 to 40 Weeks Post Menstrual Age (EOS)Population: FAS
Development of intraventricular hemorrhage was assessed by cerebral ultrasound and coded as a binary endpoint (presence or absence of IVH).
Outcome measures
| Measure |
rhIGF-1/rhIGFBP-3
n=61 Participants
Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
|
Standard of Care (Control)
n=60 Participants
Participants in this control group do not received any treatment other than the standard care.
|
|---|---|---|
|
Percentage of Participants With Intraventricular Hemorrhage (IVH)
Yes
|
19.67 percentage of participants
|
30.0 percentage of participants
|
|
Percentage of Participants With Intraventricular Hemorrhage (IVH)
No
|
80.33 percentage of participants
|
70.0 percentage of participants
|
SECONDARY outcome
Timeframe: Every 1-2 weeks starting at 31 weeks PMA/ EOS +/- 4 daysPopulation: Full analysis set with number of participants evaluable for this outcome.
Integration of the maximum severity of ROP stage and the duration of the time interval with respect to each retinal examination. AUC for the maximum severity of ROP was calculated using the trapezoidal rule. The area between each 2 visits was calculated by multiplying the average of the maximum severities of the 2 visits by the difference in days and analyzed using the van Elteren test. ROP is classified according to the International Classification and is subdivided into 5 stages (1-5) with higher values representing greater severity.
Outcome measures
| Measure |
rhIGF-1/rhIGFBP-3
n=42 Participants
Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
|
Standard of Care (Control)
n=49 Participants
Participants in this control group do not received any treatment other than the standard care.
|
|---|---|---|
|
Area Under Curve for Maximum Severity of ROP Stage (AUC for ROP)
|
47.95 ROP severity score*days
Standard Deviation 47.384
|
32.17 ROP severity score*days
Standard Deviation 40.151
|
SECONDARY outcome
Timeframe: Day 0 to 40 Weeks Post Menstrual Age (EOS)Population: FAS.
ROP was measured by central exams with fundus photography. Maximum severity of ROP stage across all retinal examinations included International Classification of Retinopathy of Prematurity, a 5 stage system, for the classification of ROP with 7 different outcomes of the ROP stage in each retinal examination: 0, 1, 2, 3, 3+, 4, and 5. This is an ordinal scale with higher numbers indicating a more severe outcome.
Outcome measures
| Measure |
rhIGF-1/rhIGFBP-3
n=61 Participants
Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
|
Standard of Care (Control)
n=60 Participants
Participants in this control group do not received any treatment other than the standard care.
|
|---|---|---|
|
Percentage of Participants With Maximum Severity of ROP Stage Greater Than or Equal to 3 at Any Time During the Study
Yes
|
25.53 Percentage of participants
|
18.00 Percentage of participants
|
|
Percentage of Participants With Maximum Severity of ROP Stage Greater Than or Equal to 3 at Any Time During the Study
No
|
74.47 Percentage of participants
|
82.00 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 0 to 40 Weeks Post Menstrual Age (EOS)Population: Safety Analysis Set (SAF) included all randomized participants who received the study drug and participants in the control group who received standard of care, and for whom at least 1 safety assessment was completed.
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product.
Outcome measures
| Measure |
rhIGF-1/rhIGFBP-3
n=61 Participants
Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
|
Standard of Care (Control)
n=60 Participants
Participants in this control group do not received any treatment other than the standard care.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE)
Participants with TEAE
|
60 participants
|
60 participants
|
|
Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE)
Participants with TESAE
|
48 participants
|
37 participants
|
SECONDARY outcome
Timeframe: Day 0 to 40 Weeks Post Menstrual Age (EOS)Population: FAS was analysed.
Serum samples were collected from treated and control participants for quantification of IGF-1 using validated immunoassays. Target range of serum IGF-1 was 28-109 mcg/L. The percentage of serum IGF-1 levels across treated participants that fall within the range was reported.
Outcome measures
| Measure |
rhIGF-1/rhIGFBP-3
n=61 Participants
Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
|
Standard of Care (Control)
n=60 Participants
Participants in this control group do not received any treatment other than the standard care.
|
|---|---|---|
|
Percentage of Serum IGF-1 Concentrations Falling Within Target Range After Infusion of rhIGF-1/rhIGFBP-3
|
66.23 percentage of serum concentration
|
6.28 percentage of serum concentration
|
SECONDARY outcome
Timeframe: Day 0 and Week 40 Post Menstrual AgePopulation: FAS.
Outcome measures
| Measure |
rhIGF-1/rhIGFBP-3
n=61 Participants
Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
|
Standard of Care (Control)
n=60 Participants
Participants in this control group do not received any treatment other than the standard care.
|
|---|---|---|
|
Serum Concentrations of IGFBP-3 After Intravenous (IV) Infusion of rhIGF-1/rhIGFBP-3
Day 0
|
494.2 microgram per liter
Standard Deviation 200.38
|
469.9 microgram per liter
Standard Deviation 180.52
|
|
Serum Concentrations of IGFBP-3 After Intravenous (IV) Infusion of rhIGF-1/rhIGFBP-3
Week 40
|
830.1 microgram per liter
Standard Deviation 200.17
|
882.1 microgram per liter
Standard Deviation 274.43
|
SECONDARY outcome
Timeframe: Day 7 and Week 40 Post Menstrual AgePopulation: FAS.
Outcome measures
| Measure |
rhIGF-1/rhIGFBP-3
n=61 Participants
Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
|
Standard of Care (Control)
n=60 Participants
Participants in this control group do not received any treatment other than the standard care.
|
|---|---|---|
|
Serum Concentrations of Acid Labile Sub-unit (ALS) After Intravenous (IV) Infusion of rhIGF-1/rhIGFBP-3
Day 7
|
411.9 microgram per liter
Standard Deviation 237.91
|
500.3 microgram per liter
Standard Deviation 350.59
|
|
Serum Concentrations of Acid Labile Sub-unit (ALS) After Intravenous (IV) Infusion of rhIGF-1/rhIGFBP-3
Week 40
|
1804.6 microgram per liter
Standard Deviation 629.61
|
2114.3 microgram per liter
Standard Deviation 941.94
|
Adverse Events
rhIGF-I/rhIGFBP-3
Serious events: 48 serious events
Other events: 58 other events
Deaths: 0 deaths
Standard of Care (Control)
Serious events: 37 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
rhIGF-I/rhIGFBP-3
n=61 participants at risk
Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
|
Standard of Care (Control)
n=60 participants at risk
Participants in this control group do not received any treatment other than the standard care.
|
|---|---|---|
|
Blood and lymphatic system disorders
Coagulation disorder neonatal
|
1.6%
1/61 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
0.00%
0/60 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia neonatal
|
0.00%
0/61 • From Day 0 upto 4 days from PMA 40 Weeks
|
1.7%
1/60 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Vascular disorders
Neonatal hypotension
|
3.3%
2/61 • Number of events 2 • From Day 0 upto 4 days from PMA 40 Weeks
|
5.0%
3/60 • Number of events 3 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/61 • From Day 0 upto 4 days from PMA 40 Weeks
|
1.7%
1/60 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Vascular disorders
Shock
|
0.00%
0/61 • From Day 0 upto 4 days from PMA 40 Weeks
|
1.7%
1/60 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Vascular disorders
Vena cava thrombosis
|
1.6%
1/61 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
0.00%
0/60 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Eye disorders
Retinopathy of prematurity
|
8.2%
5/61 • Number of events 6 • From Day 0 upto 4 days from PMA 40 Weeks
|
3.3%
2/60 • Number of events 2 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/61 • From Day 0 upto 4 days from PMA 40 Weeks
|
1.7%
1/60 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/61 • From Day 0 upto 4 days from PMA 40 Weeks
|
1.7%
1/60 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Gastrointestinal disorders
Intestinal perforation
|
1.6%
1/61 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
5.0%
3/60 • Number of events 3 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Gastrointestinal disorders
Intra-Abdominal haemorrhage
|
1.6%
1/61 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
0.00%
0/60 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Gastrointestinal disorders
Intussusception
|
1.6%
1/61 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
0.00%
0/60 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Gastrointestinal disorders
Meconium ileus
|
3.3%
2/61 • Number of events 2 • From Day 0 upto 4 days from PMA 40 Weeks
|
0.00%
0/60 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Gastrointestinal disorders
Necrotising enterocolitis neonatal
|
9.8%
6/61 • Number of events 6 • From Day 0 upto 4 days from PMA 40 Weeks
|
5.0%
3/60 • Number of events 3 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/61 • From Day 0 upto 4 days from PMA 40 Weeks
|
1.7%
1/60 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
General disorders
Generalised oedema
|
1.6%
1/61 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
0.00%
0/60 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
21.3%
13/61 • Number of events 13 • From Day 0 upto 4 days from PMA 40 Weeks
|
23.3%
14/60 • Number of events 14 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Cardiac disorders
Bradycardia neonatal
|
1.6%
1/61 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
0.00%
0/60 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Cardiac disorders
Cardiac hypertrophy
|
1.6%
1/61 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
0.00%
0/60 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Cardiac disorders
Sick sinus syndrome
|
1.6%
1/61 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
0.00%
0/60 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.6%
1/61 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
0.00%
0/60 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Infections and infestations
Citrobacter sepsis
|
0.00%
0/61 • From Day 0 upto 4 days from PMA 40 Weeks
|
1.7%
1/60 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/61 • From Day 0 upto 4 days from PMA 40 Weeks
|
1.7%
1/60 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Infections and infestations
Escherichia sepsis
|
1.6%
1/61 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
5.0%
3/60 • Number of events 3 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Infections and infestations
Group b streptococcus neonatal sepsis
|
1.6%
1/61 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
1.7%
1/60 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Infections and infestations
Neonatal pneumonia
|
0.00%
0/61 • From Day 0 upto 4 days from PMA 40 Weeks
|
1.7%
1/60 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Infections and infestations
Sepsis neonatal
|
11.5%
7/61 • Number of events 8 • From Day 0 upto 4 days from PMA 40 Weeks
|
1.7%
1/60 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Infections and infestations
Serratia sepsis
|
4.9%
3/61 • Number of events 3 • From Day 0 upto 4 days from PMA 40 Weeks
|
0.00%
0/60 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Infections and infestations
Staphylococcal sepsis
|
14.8%
9/61 • Number of events 10 • From Day 0 upto 4 days from PMA 40 Weeks
|
11.7%
7/60 • Number of events 9 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Investigations
Pco2 increased
|
0.00%
0/61 • From Day 0 upto 4 days from PMA 40 Weeks
|
1.7%
1/60 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Renal and urinary disorders
Renal failure neonatal
|
4.9%
3/61 • Number of events 3 • From Day 0 upto 4 days from PMA 40 Weeks
|
1.7%
1/60 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.00%
0/61 • From Day 0 upto 4 days from PMA 40 Weeks
|
1.7%
1/60 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/61 • From Day 0 upto 4 days from PMA 40 Weeks
|
1.7%
1/60 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/61 • From Day 0 upto 4 days from PMA 40 Weeks
|
1.7%
1/60 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
1.6%
1/61 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
0.00%
0/60 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.00%
0/61 • From Day 0 upto 4 days from PMA 40 Weeks
|
1.7%
1/60 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.00%
0/61 • From Day 0 upto 4 days from PMA 40 Weeks
|
1.7%
1/60 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Nervous system disorders
Cerebral haemorrhage neonatal
|
0.00%
0/61 • From Day 0 upto 4 days from PMA 40 Weeks
|
1.7%
1/60 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Nervous system disorders
Convulsion neonatal
|
3.3%
2/61 • Number of events 2 • From Day 0 upto 4 days from PMA 40 Weeks
|
0.00%
0/60 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Nervous system disorders
Intraventricular haemorrhage neonatal
|
11.5%
7/61 • Number of events 8 • From Day 0 upto 4 days from PMA 40 Weeks
|
13.3%
8/60 • Number of events 8 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Nervous system disorders
Periventricular leukomalacia
|
6.6%
4/61 • Number of events 4 • From Day 0 upto 4 days from PMA 40 Weeks
|
1.7%
1/60 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dysplasia
|
0.00%
0/61 • From Day 0 upto 4 days from PMA 40 Weeks
|
3.3%
2/60 • Number of events 2 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Infantile apnoeic attack
|
8.2%
5/61 • Number of events 6 • From Day 0 upto 4 days from PMA 40 Weeks
|
5.0%
3/60 • Number of events 3 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal aspiration
|
0.00%
0/61 • From Day 0 upto 4 days from PMA 40 Weeks
|
1.7%
1/60 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress syndrome
|
4.9%
3/61 • Number of events 3 • From Day 0 upto 4 days from PMA 40 Weeks
|
5.0%
3/60 • Number of events 8 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory failure
|
11.5%
7/61 • Number of events 11 • From Day 0 upto 4 days from PMA 40 Weeks
|
15.0%
9/60 • Number of events 13 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/61 • From Day 0 upto 4 days from PMA 40 Weeks
|
1.7%
1/60 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.6%
1/61 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
0.00%
0/60 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
1.6%
1/61 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
3.3%
2/60 • Number of events 2 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
3.3%
2/61 • Number of events 2 • From Day 0 upto 4 days from PMA 40 Weeks
|
5.0%
3/60 • Number of events 3 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary interstitial emphysema syndrome
|
0.00%
0/61 • From Day 0 upto 4 days from PMA 40 Weeks
|
1.7%
1/60 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
Other adverse events
| Measure |
rhIGF-I/rhIGFBP-3
n=61 participants at risk
Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
|
Standard of Care (Control)
n=60 participants at risk
Participants in this control group do not received any treatment other than the standard care.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia neonatal
|
75.4%
46/61 • Number of events 210 • From Day 0 upto 4 days from PMA 40 Weeks
|
73.3%
44/60 • Number of events 157 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Blood and lymphatic system disorders
Coagulation disorder neonatal
|
14.8%
9/61 • Number of events 10 • From Day 0 upto 4 days from PMA 40 Weeks
|
13.3%
8/60 • Number of events 12 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Blood and lymphatic system disorders
Neutropenia neonatal
|
8.2%
5/61 • Number of events 5 • From Day 0 upto 4 days from PMA 40 Weeks
|
0.00%
0/60 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia neonatal
|
19.7%
12/61 • Number of events 15 • From Day 0 upto 4 days from PMA 40 Weeks
|
15.0%
9/60 • Number of events 13 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Musculoskeletal and connective tissue disorders
Growth retardation
|
1.6%
1/61 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
5.0%
3/60 • Number of events 3 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
9.8%
6/61 • Number of events 6 • From Day 0 upto 4 days from PMA 40 Weeks
|
15.0%
9/60 • Number of events 9 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Vascular disorders
Neonatal hypotension
|
37.7%
23/61 • Number of events 33 • From Day 0 upto 4 days from PMA 40 Weeks
|
25.0%
15/60 • Number of events 27 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Eye disorders
Retinopathy of prematurity
|
63.9%
39/61 • Number of events 106 • From Day 0 upto 4 days from PMA 40 Weeks
|
61.7%
37/60 • Number of events 89 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
8.2%
5/61 • Number of events 5 • From Day 0 upto 4 days from PMA 40 Weeks
|
6.7%
4/60 • Number of events 4 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
11.5%
7/61 • Number of events 9 • From Day 0 upto 4 days from PMA 40 Weeks
|
10.0%
6/60 • Number of events 6 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
1.6%
1/61 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
5.0%
3/60 • Number of events 3 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Gastrointestinal disorders
Inguinal hernia
|
14.8%
9/61 • Number of events 10 • From Day 0 upto 4 days from PMA 40 Weeks
|
18.3%
11/60 • Number of events 11 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Gastrointestinal disorders
Umbilical hernia
|
4.9%
3/61 • Number of events 3 • From Day 0 upto 4 days from PMA 40 Weeks
|
10.0%
6/60 • Number of events 6 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Gastrointestinal disorders
Vomiting neonatal
|
3.3%
2/61 • Number of events 2 • From Day 0 upto 4 days from PMA 40 Weeks
|
5.0%
3/60 • Number of events 5 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
General disorders
Generalised oedema
|
14.8%
9/61 • Number of events 15 • From Day 0 upto 4 days from PMA 40 Weeks
|
6.7%
4/60 • Number of events 5 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
General disorders
Infusion site extravasation
|
1.6%
1/61 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
5.0%
3/60 • Number of events 8 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
General disorders
Oedema peripheral
|
14.8%
9/61 • Number of events 11 • From Day 0 upto 4 days from PMA 40 Weeks
|
1.7%
1/60 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
9.8%
6/61 • Number of events 6 • From Day 0 upto 4 days from PMA 40 Weeks
|
15.0%
9/60 • Number of events 10 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
86.9%
53/61 • Number of events 67 • From Day 0 upto 4 days from PMA 40 Weeks
|
75.0%
45/60 • Number of events 57 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Cardiac disorders
Bradycardia neonatal
|
21.3%
13/61 • Number of events 18 • From Day 0 upto 4 days from PMA 40 Weeks
|
8.3%
5/60 • Number of events 6 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Cardiac disorders
Neonatal tachycardia
|
6.6%
4/61 • Number of events 8 • From Day 0 upto 4 days from PMA 40 Weeks
|
0.00%
0/60 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Infections and infestations
Fungal skin infection
|
4.9%
3/61 • Number of events 6 • From Day 0 upto 4 days from PMA 40 Weeks
|
5.0%
3/60 • Number of events 6 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Infections and infestations
Neonatal pneumonia
|
1.6%
1/61 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
5.0%
3/60 • Number of events 3 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Infections and infestations
Pneumonia bacterial
|
6.6%
4/61 • Number of events 4 • From Day 0 upto 4 days from PMA 40 Weeks
|
8.3%
5/60 • Number of events 6 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Infections and infestations
Rhinitis
|
6.6%
4/61 • Number of events 5 • From Day 0 upto 4 days from PMA 40 Weeks
|
5.0%
3/60 • Number of events 6 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Infections and infestations
Sepsis neonatal
|
26.2%
16/61 • Number of events 33 • From Day 0 upto 4 days from PMA 40 Weeks
|
25.0%
15/60 • Number of events 29 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Infections and infestations
Staphylococcal sepsis
|
14.8%
9/61 • Number of events 14 • From Day 0 upto 4 days from PMA 40 Weeks
|
20.0%
12/60 • Number of events 16 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Investigations
Blood alkaline phosphatase increased
|
8.2%
5/61 • Number of events 6 • From Day 0 upto 4 days from PMA 40 Weeks
|
10.0%
6/60 • Number of events 6 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Investigations
C-Reactive protein increased
|
8.2%
5/61 • Number of events 6 • From Day 0 upto 4 days from PMA 40 Weeks
|
6.7%
4/60 • Number of events 5 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Renal and urinary disorders
Oliguria
|
8.2%
5/61 • Number of events 5 • From Day 0 upto 4 days from PMA 40 Weeks
|
5.0%
3/60 • Number of events 4 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Hepatobiliary disorders
Hyperbilirubinaemia neonatal
|
19.7%
12/61 • Number of events 14 • From Day 0 upto 4 days from PMA 40 Weeks
|
23.3%
14/60 • Number of events 18 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Hepatobiliary disorders
Neonatal cholestasis
|
3.3%
2/61 • Number of events 2 • From Day 0 upto 4 days from PMA 40 Weeks
|
10.0%
6/60 • Number of events 6 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Metabolism and nutrition disorders
Acidosis
|
6.6%
4/61 • Number of events 5 • From Day 0 upto 4 days from PMA 40 Weeks
|
13.3%
8/60 • Number of events 9 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Metabolism and nutrition disorders
Feeding disorder neonatal
|
1.6%
1/61 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
5.0%
3/60 • Number of events 4 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
6.6%
4/61 • Number of events 5 • From Day 0 upto 4 days from PMA 40 Weeks
|
6.7%
4/60 • Number of events 8 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
39.3%
24/61 • Number of events 41 • From Day 0 upto 4 days from PMA 40 Weeks
|
46.7%
28/60 • Number of events 55 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
9.8%
6/61 • Number of events 7 • From Day 0 upto 4 days from PMA 40 Weeks
|
18.3%
11/60 • Number of events 13 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
8.2%
5/61 • Number of events 6 • From Day 0 upto 4 days from PMA 40 Weeks
|
6.7%
4/60 • Number of events 5 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
13.1%
8/61 • Number of events 20 • From Day 0 upto 4 days from PMA 40 Weeks
|
10.0%
6/60 • Number of events 6 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia neonatal
|
29.5%
18/61 • Number of events 22 • From Day 0 upto 4 days from PMA 40 Weeks
|
31.7%
19/60 • Number of events 27 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
23.0%
14/61 • Number of events 24 • From Day 0 upto 4 days from PMA 40 Weeks
|
18.3%
11/60 • Number of events 18 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
3.3%
2/61 • Number of events 2 • From Day 0 upto 4 days from PMA 40 Weeks
|
6.7%
4/60 • Number of events 5 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
1.6%
1/61 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
5.0%
3/60 • Number of events 4 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
27.9%
17/61 • Number of events 43 • From Day 0 upto 4 days from PMA 40 Weeks
|
36.7%
22/60 • Number of events 46 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Metabolism and nutrition disorders
Neonatal hyponatraemia
|
37.7%
23/61 • Number of events 43 • From Day 0 upto 4 days from PMA 40 Weeks
|
36.7%
22/60 • Number of events 39 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Nervous system disorders
Cerebral ventricle dilatation
|
0.00%
0/61 • From Day 0 upto 4 days from PMA 40 Weeks
|
5.0%
3/60 • Number of events 3 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Nervous system disorders
Convulsion neonatal
|
4.9%
3/61 • Number of events 3 • From Day 0 upto 4 days from PMA 40 Weeks
|
5.0%
3/60 • Number of events 3 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Nervous system disorders
Intraventricular haemorrhage neonatal
|
18.0%
11/61 • Number of events 13 • From Day 0 upto 4 days from PMA 40 Weeks
|
30.0%
18/60 • Number of events 19 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Nervous system disorders
Periventricular leukomalacia
|
1.6%
1/61 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
5.0%
3/60 • Number of events 3 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
|
45.9%
28/61 • Number of events 34 • From Day 0 upto 4 days from PMA 40 Weeks
|
50.0%
30/60 • Number of events 38 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Pregnancy, puerperium and perinatal conditions
Poor weight gain neonatal
|
4.9%
3/61 • Number of events 3 • From Day 0 upto 4 days from PMA 40 Weeks
|
6.7%
4/60 • Number of events 4 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Reproductive system and breast disorders
Oedema genital
|
13.1%
8/61 • Number of events 9 • From Day 0 upto 4 days from PMA 40 Weeks
|
1.7%
1/60 • Number of events 2 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis neonatal
|
4.9%
3/61 • Number of events 3 • From Day 0 upto 4 days from PMA 40 Weeks
|
6.7%
4/60 • Number of events 4 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dysplasia
|
55.7%
34/61 • Number of events 37 • From Day 0 upto 4 days from PMA 40 Weeks
|
61.7%
37/60 • Number of events 42 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
3.3%
2/61 • Number of events 2 • From Day 0 upto 4 days from PMA 40 Weeks
|
13.3%
8/60 • Number of events 11 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypocapnia
|
3.3%
2/61 • Number of events 3 • From Day 0 upto 4 days from PMA 40 Weeks
|
6.7%
4/60 • Number of events 5 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Infantile apnoeic attack
|
42.6%
26/61 • Number of events 42 • From Day 0 upto 4 days from PMA 40 Weeks
|
26.7%
16/60 • Number of events 32 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal hypoxia
|
23.0%
14/61 • Number of events 17 • From Day 0 upto 4 days from PMA 40 Weeks
|
21.7%
13/60 • Number of events 21 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory acidosis
|
16.4%
10/61 • Number of events 30 • From Day 0 upto 4 days from PMA 40 Weeks
|
8.3%
5/60 • Number of events 11 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress syndrome
|
44.3%
27/61 • Number of events 31 • From Day 0 upto 4 days from PMA 40 Weeks
|
53.3%
32/60 • Number of events 41 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory failure
|
14.8%
9/61 • Number of events 11 • From Day 0 upto 4 days from PMA 40 Weeks
|
8.3%
5/60 • Number of events 5 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal tachypnoea
|
3.3%
2/61 • Number of events 2 • From Day 0 upto 4 days from PMA 40 Weeks
|
6.7%
4/60 • Number of events 5 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
6.6%
4/61 • Number of events 4 • From Day 0 upto 4 days from PMA 40 Weeks
|
0.00%
0/60 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
9.8%
6/61 • Number of events 6 • From Day 0 upto 4 days from PMA 40 Weeks
|
15.0%
9/60 • Number of events 11 • From Day 0 upto 4 days from PMA 40 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema neonatal
|
9.8%
6/61 • Number of events 7 • From Day 0 upto 4 days from PMA 40 Weeks
|
1.7%
1/60 • Number of events 1 • From Day 0 upto 4 days from PMA 40 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER