Trial Outcomes & Findings for SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants. (NCT NCT00215540)
NCT ID: NCT00215540
Last Updated: 2012-06-13
Results Overview
Number of participants who died or developed BPD, defined as oxygen requirement at 36 Weeks post-menstrual age
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
136 participants
Primary outcome timeframe
36 weeks post-menstrual age (PMA)
Results posted on
2012-06-13
Participant Flow
Participant milestones
| Measure |
SURFAXIN High Dose
SURFAXIN (lucinactant) at 175 mg/kg
|
SURFAXIN Low Dose
SURFAXIN (lucinactant) at 90 mg/kg
|
Placebo
Sham air using 3.0 mL/kg volume of air
|
|---|---|---|---|
|
Overall Study
STARTED
|
45
|
47
|
44
|
|
Overall Study
COMPLETED
|
44
|
47
|
44
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
SURFAXIN High Dose
SURFAXIN (lucinactant) at 175 mg/kg
|
SURFAXIN Low Dose
SURFAXIN (lucinactant) at 90 mg/kg
|
Placebo
Sham air using 3.0 mL/kg volume of air
|
|---|---|---|---|
|
Overall Study
Withdrew from study medication
|
1
|
0
|
0
|
Baseline Characteristics
SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants.
Baseline characteristics by cohort
| Measure |
SURFAXIN High Dose
n=45 Participants
SURFAXIN (lucinactant) at 175 mg/kg
|
SURFAXIN Low Dose
n=47 Participants
SURFAXIN (lucinactant) at 90 mg/kg
|
Placebo
n=44 Participants
Sham air using 3.0 mL/kg volume of air
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
45 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
136 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
20 participants
n=7 Participants
|
19 participants
n=5 Participants
|
56 participants
n=4 Participants
|
|
Region of Enrollment
Chile
|
8 participants
n=5 Participants
|
10 participants
n=7 Participants
|
7 participants
n=5 Participants
|
25 participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
17 participants
n=5 Participants
|
14 participants
n=7 Participants
|
16 participants
n=5 Participants
|
47 participants
n=4 Participants
|
|
Region of Enrollment
Hungary
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Gestational Age
|
26.1 weeks
STANDARD_DEVIATION 1.68 • n=5 Participants
|
25.5 weeks
STANDARD_DEVIATION 1.43 • n=7 Participants
|
25.7 weeks
STANDARD_DEVIATION 1.36 • n=5 Participants
|
25.8 weeks
STANDARD_DEVIATION 1.49 • n=4 Participants
|
PRIMARY outcome
Timeframe: 36 weeks post-menstrual age (PMA)Population: A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)
Number of participants who died or developed BPD, defined as oxygen requirement at 36 Weeks post-menstrual age
Outcome measures
| Measure |
SURFAXIN High Dose
n=45 Participants
SURFAXIN (lucinactant) at 175 mg/kg
|
SURFAXIN Low Dose
n=47 Participants
SURFAXIN (lucinactant) at 90 mg/kg
|
Placebo
n=44 Participants
Sham air using 3.0 mL/kg volume of air
|
|---|---|---|---|
|
Incidence of Death or Bronchopulmonary Dysplasia (BPD) at 36 Weeks
|
26 participants
|
37 participants
|
29 participants
|
PRIMARY outcome
Timeframe: 36 weeks PMAPopulation: A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)
Outcome measures
| Measure |
SURFAXIN High Dose
n=45 Participants
SURFAXIN (lucinactant) at 175 mg/kg
|
SURFAXIN Low Dose
n=47 Participants
SURFAXIN (lucinactant) at 90 mg/kg
|
Placebo
n=44 Participants
Sham air using 3.0 mL/kg volume of air
|
|---|---|---|---|
|
All-cause Mortality
|
5 participants
|
14 participants
|
7 participants
|
SECONDARY outcome
Timeframe: 28 days of lifePopulation: A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)
BPD at 28 days of life, as determined by the need for supplemental oxygen
Outcome measures
| Measure |
SURFAXIN High Dose
n=45 Participants
SURFAXIN (lucinactant) at 175 mg/kg
|
SURFAXIN Low Dose
n=47 Participants
SURFAXIN (lucinactant) at 90 mg/kg
|
Placebo
n=44 Participants
Sham air using 3.0 mL/kg volume of air
|
|---|---|---|---|
|
BPD at 28 Days
|
42 participants
|
44 participants
|
38 participants
|
SECONDARY outcome
Timeframe: 36 weeks PMAPopulation: A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)
BPD at 36 weeks PMA as determined by the need for supplemental oxygen
Outcome measures
| Measure |
SURFAXIN High Dose
n=45 Participants
SURFAXIN (lucinactant) at 175 mg/kg
|
SURFAXIN Low Dose
n=47 Participants
SURFAXIN (lucinactant) at 90 mg/kg
|
Placebo
n=44 Participants
Sham air using 3.0 mL/kg volume of air
|
|---|---|---|---|
|
BPD at 36 Weeks
|
26 participants
|
37 participants
|
29 participants
|
SECONDARY outcome
Timeframe: 36 weeks PMAPopulation: A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)
Number of days receiving mechanical ventilation
Outcome measures
| Measure |
SURFAXIN High Dose
n=45 Participants
SURFAXIN (lucinactant) at 175 mg/kg
|
SURFAXIN Low Dose
n=47 Participants
SURFAXIN (lucinactant) at 90 mg/kg
|
Placebo
n=44 Participants
Sham air using 3.0 mL/kg volume of air
|
|---|---|---|---|
|
Days Receiving Mechanical Ventilation (MV)
|
30.1 days
Standard Deviation 23.3
|
42.1 days
Standard Deviation 26.4
|
35.8 days
Standard Deviation 23.2
|
SECONDARY outcome
Timeframe: 36 weeks PMAPopulation: A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)
Number of days receiving supplemental oxygen through 36 weeks PMA
Outcome measures
| Measure |
SURFAXIN High Dose
n=45 Participants
SURFAXIN (lucinactant) at 175 mg/kg
|
SURFAXIN Low Dose
n=47 Participants
SURFAXIN (lucinactant) at 90 mg/kg
|
Placebo
n=44 Participants
Sham air using 3.0 mL/kg volume of air
|
|---|---|---|---|
|
Duration of Supplemental Oxygen
|
55.3 days
Standard Deviation 16.8
|
63.0 days
Standard Deviation 19.3
|
55.7 days
Standard Deviation 23.4
|
SECONDARY outcome
Timeframe: 15 minutes prior to dose 1, 2 hours post dose 1, 6 hours post dose 1, 24 hours post dose 1, and daily from Study Day 2 to Study Day 25 and Day of Life 28Population: A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)
AUC for FiO₂calculated using the trapezoidal rule. Missing data imputed using last observation carried forward
Outcome measures
| Measure |
SURFAXIN High Dose
n=45 Participants
SURFAXIN (lucinactant) at 175 mg/kg
|
SURFAXIN Low Dose
n=47 Participants
SURFAXIN (lucinactant) at 90 mg/kg
|
Placebo
n=44 Participants
Sham air using 3.0 mL/kg volume of air
|
|---|---|---|---|
|
Area Under the Curve for Fraction of Inspired Oxygen (FiO₂)
|
0.39 Percent O₂*hour
Standard Deviation 0.14
|
0.41 Percent O₂*hour
Standard Deviation 0.16
|
0.38 Percent O₂*hour
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: 15 minutes prior to dose 1, 2 hours post dose 1, 6 hours post dose 1, 24 hours post dose 1, and daily from Study Day 2 to Study Day 25, and day of life 28Population: A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)
AUC for MAP (in mm Hg) calculated using the trapezoidal rule. Missing data imputed using last observation carried forward
Outcome measures
| Measure |
SURFAXIN High Dose
n=45 Participants
SURFAXIN (lucinactant) at 175 mg/kg
|
SURFAXIN Low Dose
n=47 Participants
SURFAXIN (lucinactant) at 90 mg/kg
|
Placebo
n=44 Participants
Sham air using 3.0 mL/kg volume of air
|
|---|---|---|---|
|
Area Under the Curve for Mean Arterial Pressure (MAP)
|
5.99 arterial pressure (mm Hg)*hour
Standard Deviation 3.38
|
6.93 arterial pressure (mm Hg)*hour
Standard Deviation 4.13
|
6.34 arterial pressure (mm Hg)*hour
Standard Deviation 3.56
|
SECONDARY outcome
Timeframe: 28 days of lifePopulation: A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)
Death or BPD, defined as oxygen requirement at 28 days of life
Outcome measures
| Measure |
SURFAXIN High Dose
n=45 Participants
SURFAXIN (lucinactant) at 175 mg/kg
|
SURFAXIN Low Dose
n=47 Participants
SURFAXIN (lucinactant) at 90 mg/kg
|
Placebo
n=44 Participants
Sham air using 3.0 mL/kg volume of air
|
|---|---|---|---|
|
Incidence of Death or BPD at 28 Days
|
42 participants
|
44 participants
|
38 participants
|
SECONDARY outcome
Timeframe: 36 weeks PMAPopulation: A sample size of 70 per arm is sufficient to demonstrate a 20% relative risk reduction. All randomized infants were analyzed (intent-to-treat)
The number of days spent in the hospital through 36 weeks PMA
Outcome measures
| Measure |
SURFAXIN High Dose
n=45 Participants
SURFAXIN (lucinactant) at 175 mg/kg
|
SURFAXIN Low Dose
n=47 Participants
SURFAXIN (lucinactant) at 90 mg/kg
|
Placebo
n=44 Participants
Sham air using 3.0 mL/kg volume of air
|
|---|---|---|---|
|
Days in Hospital
|
65.8 days
Standard Deviation 11.72
|
70.0 days
Standard Deviation 10.06
|
68.6 days
Standard Deviation 9.57
|
Adverse Events
SURFAXIN High Dose
Serious events: 33 serious events
Other events: 45 other events
Deaths: 0 deaths
SURFAXIN Low Dose
Serious events: 36 serious events
Other events: 47 other events
Deaths: 0 deaths
Placebo
Serious events: 35 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SURFAXIN High Dose
n=45 participants at risk
SURFAXIN (lucinactant) at 175 mg/kg
|
SURFAXIN Low Dose
n=47 participants at risk
SURFAXIN (lucinactant) at 90 mg/kg
|
Placebo
n=44 participants at risk
Sham air using 3.0 mL/kg volume of air
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/45 • Through 36 weeks PMA
|
2.1%
1/47 • Number of events 1 • Through 36 weeks PMA
|
0.00%
0/44 • Through 36 weeks PMA
|
|
Cardiac disorders
Bradycardia NOS
|
2.2%
1/45 • Number of events 1 • Through 36 weeks PMA
|
4.3%
2/47 • Number of events 2 • Through 36 weeks PMA
|
2.3%
1/44 • Number of events 1 • Through 36 weeks PMA
|
|
Cardiac disorders
Cardiac arrest
|
2.2%
1/45 • Number of events 1 • Through 36 weeks PMA
|
0.00%
0/47 • Through 36 weeks PMA
|
2.3%
1/44 • Number of events 2 • Through 36 weeks PMA
|
|
Cardiac disorders
Cardiac arrest neonatal
|
2.2%
1/45 • Number of events 1 • Through 36 weeks PMA
|
0.00%
0/47 • Through 36 weeks PMA
|
0.00%
0/44 • Through 36 weeks PMA
|
|
Cardiac disorders
Cardio-respiratory arrest neonatal
|
0.00%
0/45 • Through 36 weeks PMA
|
2.1%
1/47 • Number of events 1 • Through 36 weeks PMA
|
0.00%
0/44 • Through 36 weeks PMA
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/45 • Through 36 weeks PMA
|
0.00%
0/47 • Through 36 weeks PMA
|
2.3%
1/44 • Number of events 1 • Through 36 weeks PMA
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
6.7%
3/45 • Number of events 3 • Through 36 weeks PMA
|
6.4%
3/47 • Number of events 3 • Through 36 weeks PMA
|
2.3%
1/44 • Number of events 1 • Through 36 weeks PMA
|
|
Eye disorders
Retrolental fibro-dysplasia
|
17.8%
8/45 • Number of events 8 • Through 36 weeks PMA
|
19.1%
9/47 • Number of events 9 • Through 36 weeks PMA
|
18.2%
8/44 • Number of events 8 • Through 36 weeks PMA
|
|
Gastrointestinal disorders
Ileal perforation
|
2.2%
1/45 • Number of events 1 • Through 36 weeks PMA
|
2.1%
1/47 • Number of events 1 • Through 36 weeks PMA
|
2.3%
1/44 • Number of events 1 • Through 36 weeks PMA
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/45 • Through 36 weeks PMA
|
0.00%
0/47 • Through 36 weeks PMA
|
2.3%
1/44 • Number of events 2 • Through 36 weeks PMA
|
|
Gastrointestinal disorders
Inguinal hernia NOS
|
2.2%
1/45 • Number of events 1 • Through 36 weeks PMA
|
0.00%
0/47 • Through 36 weeks PMA
|
0.00%
0/44 • Through 36 weeks PMA
|
|
Gastrointestinal disorders
Intestinal obstruction NOS
|
0.00%
0/45 • Through 36 weeks PMA
|
0.00%
0/47 • Through 36 weeks PMA
|
2.3%
1/44 • Number of events 1 • Through 36 weeks PMA
|
|
Gastrointestinal disorders
Intestinal perforation NOS
|
2.2%
1/45 • Number of events 1 • Through 36 weeks PMA
|
0.00%
0/47 • Through 36 weeks PMA
|
0.00%
0/44 • Through 36 weeks PMA
|
|
Gastrointestinal disorders
Meconium ileus
|
2.2%
1/45 • Number of events 1 • Through 36 weeks PMA
|
2.1%
1/47 • Number of events 1 • Through 36 weeks PMA
|
0.00%
0/44 • Through 36 weeks PMA
|
|
Gastrointestinal disorders
Necrotising enterocolitis
|
8.9%
4/45 • Number of events 4 • Through 36 weeks PMA
|
10.6%
5/47 • Number of events 5 • Through 36 weeks PMA
|
2.3%
1/44 • Number of events 1 • Through 36 weeks PMA
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/45 • Through 36 weeks PMA
|
0.00%
0/47 • Through 36 weeks PMA
|
2.3%
1/44 • Number of events 1 • Through 36 weeks PMA
|
|
General disorders
Multi-organ failure
|
0.00%
0/45 • Through 36 weeks PMA
|
2.1%
1/47 • Number of events 1 • Through 36 weeks PMA
|
0.00%
0/44 • Through 36 weeks PMA
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/45 • Through 36 weeks PMA
|
2.1%
1/47 • Number of events 1 • Through 36 weeks PMA
|
2.3%
1/44 • Number of events 1 • Through 36 weeks PMA
|
|
Infections and infestations
Bronchopneumonia NOS
|
2.2%
1/45 • Number of events 1 • Through 36 weeks PMA
|
0.00%
0/47 • Through 36 weeks PMA
|
0.00%
0/44 • Through 36 weeks PMA
|
|
Infections and infestations
Neonatal meningitis
|
0.00%
0/45 • Through 36 weeks PMA
|
2.1%
1/47 • Number of events 1 • Through 36 weeks PMA
|
0.00%
0/44 • Through 36 weeks PMA
|
|
Infections and infestations
Pneumonia NOS
|
2.2%
1/45 • Number of events 1 • Through 36 weeks PMA
|
2.1%
1/47 • Number of events 1 • Through 36 weeks PMA
|
2.3%
1/44 • Number of events 2 • Through 36 weeks PMA
|
|
Infections and infestations
Sepsis NOS
|
8.9%
4/45 • Number of events 4 • Through 36 weeks PMA
|
0.00%
0/47 • Through 36 weeks PMA
|
2.3%
1/44 • Number of events 1 • Through 36 weeks PMA
|
|
Infections and infestations
Sepsis neonatal
|
6.7%
3/45 • Number of events 3 • Through 36 weeks PMA
|
12.8%
6/47 • Number of events 6 • Through 36 weeks PMA
|
13.6%
6/44 • Number of events 6 • Through 36 weeks PMA
|
|
Infections and infestations
Septic shock
|
0.00%
0/45 • Through 36 weeks PMA
|
0.00%
0/47 • Through 36 weeks PMA
|
2.3%
1/44 • Number of events 1 • Through 36 weeks PMA
|
|
Infections and infestations
Septicaemia serratia
|
0.00%
0/45 • Through 36 weeks PMA
|
0.00%
0/47 • Through 36 weeks PMA
|
2.3%
1/44 • Number of events 1 • Through 36 weeks PMA
|
|
Infections and infestations
Septicaemia staphylococcal
|
8.9%
4/45 • Number of events 4 • Through 36 weeks PMA
|
10.6%
5/47 • Number of events 5 • Through 36 weeks PMA
|
9.1%
4/44 • Number of events 4 • Through 36 weeks PMA
|
|
Injury, poisoning and procedural complications
Abrasion NOS
|
0.00%
0/45 • Through 36 weeks PMA
|
0.00%
0/47 • Through 36 weeks PMA
|
2.3%
1/44 • Number of events 1 • Through 36 weeks PMA
|
|
Investigations
Oxygen saturation decreased
|
4.4%
2/45 • Number of events 2 • Through 36 weeks PMA
|
8.5%
4/47 • Number of events 8 • Through 36 weeks PMA
|
4.5%
2/44 • Number of events 2 • Through 36 weeks PMA
|
|
Metabolism and nutrition disorders
Diabetes mellitus NOS
|
0.00%
0/45 • Through 36 weeks PMA
|
0.00%
0/47 • Through 36 weeks PMA
|
2.3%
1/44 • Number of events 1 • Through 36 weeks PMA
|
|
Metabolism and nutrition disorders
Metabolic acidosis NOS
|
0.00%
0/45 • Through 36 weeks PMA
|
0.00%
0/47 • Through 36 weeks PMA
|
2.3%
1/44 • Number of events 1 • Through 36 weeks PMA
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
0.00%
0/45 • Through 36 weeks PMA
|
0.00%
0/47 • Through 36 weeks PMA
|
2.3%
1/44 • Number of events 1 • Through 36 weeks PMA
|
|
Nervous system disorders
Convulsions NOS
|
0.00%
0/45 • Through 36 weeks PMA
|
2.1%
1/47 • Number of events 1 • Through 36 weeks PMA
|
2.3%
1/44 • Number of events 1 • Through 36 weeks PMA
|
|
Nervous system disorders
Hydrocephalus NOS
|
2.2%
1/45 • Number of events 1 • Through 36 weeks PMA
|
2.1%
1/47 • Number of events 1 • Through 36 weeks PMA
|
0.00%
0/44 • Through 36 weeks PMA
|
|
Nervous system disorders
Neurological disorder NOS
|
6.7%
3/45 • Number of events 3 • Through 36 weeks PMA
|
6.4%
3/47 • Number of events 3 • Through 36 weeks PMA
|
2.3%
1/44 • Number of events 1 • Through 36 weeks PMA
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/45 • Through 36 weeks PMA
|
0.00%
0/47 • Through 36 weeks PMA
|
2.3%
1/44 • Number of events 1 • Through 36 weeks PMA
|
|
Renal and urinary disorders
Renal failure neonatal
|
0.00%
0/45 • Through 36 weeks PMA
|
10.6%
5/47 • Number of events 5 • Through 36 weeks PMA
|
2.3%
1/44 • Number of events 1 • Through 36 weeks PMA
|
|
Renal and urinary disorders
Urinary tract infection NOS neonatal
|
0.00%
0/45 • Through 36 weeks PMA
|
0.00%
0/47 • Through 36 weeks PMA
|
2.3%
1/44 • Number of events 1 • Through 36 weeks PMA
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/45 • Through 36 weeks PMA
|
2.1%
1/47 • Number of events 2 • Through 36 weeks PMA
|
0.00%
0/44 • Through 36 weeks PMA
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/45 • Through 36 weeks PMA
|
0.00%
0/47 • Through 36 weeks PMA
|
2.3%
1/44 • Number of events 1 • Through 36 weeks PMA
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis neonatal
|
2.2%
1/45 • Number of events 1 • Through 36 weeks PMA
|
0.00%
0/47 • Through 36 weeks PMA
|
0.00%
0/44 • Through 36 weeks PMA
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dysplasia
|
13.3%
6/45 • Number of events 6 • Through 36 weeks PMA
|
14.9%
7/47 • Number of events 8 • Through 36 weeks PMA
|
20.5%
9/44 • Number of events 9 • Through 36 weeks PMA
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/45 • Through 36 weeks PMA
|
4.3%
2/47 • Number of events 4 • Through 36 weeks PMA
|
0.00%
0/44 • Through 36 weeks PMA
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal apnoeic attack
|
2.2%
1/45 • Number of events 1 • Through 36 weeks PMA
|
6.4%
3/47 • Number of events 3 • Through 36 weeks PMA
|
4.5%
2/44 • Number of events 2 • Through 36 weeks PMA
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal hypoxia
|
4.4%
2/45 • Number of events 5 • Through 36 weeks PMA
|
2.1%
1/47 • Number of events 1 • Through 36 weeks PMA
|
0.00%
0/44 • Through 36 weeks PMA
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory acidosis
|
2.2%
1/45 • Number of events 1 • Through 36 weeks PMA
|
2.1%
1/47 • Number of events 1 • Through 36 weeks PMA
|
0.00%
0/44 • Through 36 weeks PMA
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory failure
|
4.4%
2/45 • Number of events 2 • Through 36 weeks PMA
|
2.1%
1/47 • Number of events 1 • Through 36 weeks PMA
|
0.00%
0/44 • Through 36 weeks PMA
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/45 • Through 36 weeks PMA
|
2.1%
1/47 • Number of events 1 • Through 36 weeks PMA
|
0.00%
0/44 • Through 36 weeks PMA
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax NOS
|
11.1%
5/45 • Number of events 7 • Through 36 weeks PMA
|
10.6%
5/47 • Number of events 5 • Through 36 weeks PMA
|
6.8%
3/44 • Number of events 3 • Through 36 weeks PMA
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
2.2%
1/45 • Number of events 2 • Through 36 weeks PMA
|
0.00%
0/47 • Through 36 weeks PMA
|
2.3%
1/44 • Number of events 1 • Through 36 weeks PMA
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary interstitial emphysema syndrome
|
0.00%
0/45 • Through 36 weeks PMA
|
2.1%
1/47 • Number of events 1 • Through 36 weeks PMA
|
4.5%
2/44 • Number of events 2 • Through 36 weeks PMA
|
|
Surgical and medical procedures
Patent ductus arteriosus repair
|
15.6%
7/45 • Number of events 7 • Through 36 weeks PMA
|
17.0%
8/47 • Number of events 8 • Through 36 weeks PMA
|
18.2%
8/44 • Number of events 8 • Through 36 weeks PMA
|
|
Vascular disorders
Circulatory failure neonatal
|
2.2%
1/45 • Number of events 1 • Through 36 weeks PMA
|
0.00%
0/47 • Through 36 weeks PMA
|
0.00%
0/44 • Through 36 weeks PMA
|
|
Vascular disorders
Intracranial haemorrhage NOS
|
0.00%
0/45 • Through 36 weeks PMA
|
2.1%
1/47 • Number of events 1 • Through 36 weeks PMA
|
0.00%
0/44 • Through 36 weeks PMA
|
|
Vascular disorders
Intraventricular haemorrhage neonatal
|
8.9%
4/45 • Number of events 4 • Through 36 weeks PMA
|
19.1%
9/47 • Number of events 9 • Through 36 weeks PMA
|
15.9%
7/44 • Number of events 8 • Through 36 weeks PMA
|
|
Vascular disorders
Neonatal hypotension
|
2.2%
1/45 • Number of events 1 • Through 36 weeks PMA
|
2.1%
1/47 • Number of events 1 • Through 36 weeks PMA
|
2.3%
1/44 • Number of events 1 • Through 36 weeks PMA
|
Other adverse events
| Measure |
SURFAXIN High Dose
n=45 participants at risk
SURFAXIN (lucinactant) at 175 mg/kg
|
SURFAXIN Low Dose
n=47 participants at risk
SURFAXIN (lucinactant) at 90 mg/kg
|
Placebo
n=44 participants at risk
Sham air using 3.0 mL/kg volume of air
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia NOS
|
22.2%
10/45 • Number of events 27 • Through 36 weeks PMA
|
12.8%
6/47 • Number of events 8 • Through 36 weeks PMA
|
18.2%
8/44 • Number of events 20 • Through 36 weeks PMA
|
|
Blood and lymphatic system disorders
Anaemia neonatal
|
53.3%
24/45 • Number of events 41 • Through 36 weeks PMA
|
53.2%
25/47 • Number of events 37 • Through 36 weeks PMA
|
56.8%
25/44 • Number of events 38 • Through 36 weeks PMA
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.2%
1/45 • Number of events 1 • Through 36 weeks PMA
|
0.00%
0/47 • Through 36 weeks PMA
|
11.4%
5/44 • Number of events 5 • Through 36 weeks PMA
|
|
Blood and lymphatic system disorders
Thrombocytopenia neonatal
|
13.3%
6/45 • Number of events 6 • Through 36 weeks PMA
|
14.9%
7/47 • Number of events 8 • Through 36 weeks PMA
|
22.7%
10/44 • Number of events 10 • Through 36 weeks PMA
|
|
Cardiac disorders
Bradycardia NOS
|
35.6%
16/45 • Number of events 29 • Through 36 weeks PMA
|
42.6%
20/47 • Number of events 51 • Through 36 weeks PMA
|
18.2%
8/44 • Number of events 11 • Through 36 weeks PMA
|
|
Cardiac disorders
Neonatal tachycardia
|
0.00%
0/45 • Through 36 weeks PMA
|
4.3%
2/47 • Number of events 2 • Through 36 weeks PMA
|
6.8%
3/44 • Number of events 3 • Through 36 weeks PMA
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
31.1%
14/45 • Number of events 15 • Through 36 weeks PMA
|
23.4%
11/47 • Number of events 13 • Through 36 weeks PMA
|
36.4%
16/44 • Number of events 16 • Through 36 weeks PMA
|
|
Endocrine disorders
Hypothyroidism
|
6.7%
3/45 • Number of events 3 • Through 36 weeks PMA
|
4.3%
2/47 • Number of events 2 • Through 36 weeks PMA
|
9.1%
4/44 • Number of events 4 • Through 36 weeks PMA
|
|
Eye disorders
Retrolental fibro-dysplasia
|
60.0%
27/45 • Number of events 30 • Through 36 weeks PMA
|
61.7%
29/47 • Number of events 35 • Through 36 weeks PMA
|
65.9%
29/44 • Number of events 35 • Through 36 weeks PMA
|
|
Gastrointestinal disorders
Gastro-oesophageal reflux disease
|
13.3%
6/45 • Number of events 6 • Through 36 weeks PMA
|
25.5%
12/47 • Number of events 12 • Through 36 weeks PMA
|
20.5%
9/44 • Number of events 9 • Through 36 weeks PMA
|
|
Gastrointestinal disorders
Inguinal hernia NOS
|
11.1%
5/45 • Number of events 7 • Through 36 weeks PMA
|
14.9%
7/47 • Number of events 7 • Through 36 weeks PMA
|
9.1%
4/44 • Number of events 4 • Through 36 weeks PMA
|
|
Gastrointestinal disorders
Necrotising enterocolitis
|
17.8%
8/45 • Number of events 8 • Through 36 weeks PMA
|
21.3%
10/47 • Number of events 10 • Through 36 weeks PMA
|
11.4%
5/44 • Number of events 5 • Through 36 weeks PMA
|
|
General disorders
Oedema NOS
|
4.4%
2/45 • Number of events 2 • Through 36 weeks PMA
|
2.1%
1/47 • Number of events 1 • Through 36 weeks PMA
|
15.9%
7/44 • Number of events 7 • Through 36 weeks PMA
|
|
Hepatobiliary disorders
Cholestasis
|
6.7%
3/45 • Number of events 3 • Through 36 weeks PMA
|
4.3%
2/47 • Number of events 2 • Through 36 weeks PMA
|
13.6%
6/44 • Number of events 6 • Through 36 weeks PMA
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
8.9%
4/45 • Number of events 4 • Through 36 weeks PMA
|
6.4%
3/47 • Number of events 3 • Through 36 weeks PMA
|
18.2%
8/44 • Number of events 8 • Through 36 weeks PMA
|
|
Hepatobiliary disorders
Hypoproteinaemia
|
4.4%
2/45 • Number of events 2 • Through 36 weeks PMA
|
4.3%
2/47 • Number of events 2 • Through 36 weeks PMA
|
9.1%
4/44 • Number of events 4 • Through 36 weeks PMA
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/45 • Through 36 weeks PMA
|
4.3%
2/47 • Number of events 2 • Through 36 weeks PMA
|
6.8%
3/44 • Number of events 4 • Through 36 weeks PMA
|
|
Infections and infestations
Pneumonia NOS
|
15.6%
7/45 • Number of events 7 • Through 36 weeks PMA
|
12.8%
6/47 • Number of events 6 • Through 36 weeks PMA
|
9.1%
4/44 • Number of events 6 • Through 36 weeks PMA
|
|
Infections and infestations
Sepsis NOS
|
8.9%
4/45 • Number of events 5 • Through 36 weeks PMA
|
6.4%
3/47 • Number of events 3 • Through 36 weeks PMA
|
6.8%
3/44 • Number of events 5 • Through 36 weeks PMA
|
|
Infections and infestations
Sepsis Neonatal
|
15.6%
7/45 • Number of events 8 • Through 36 weeks PMA
|
36.2%
17/47 • Number of events 19 • Through 36 weeks PMA
|
27.3%
12/44 • Number of events 15 • Through 36 weeks PMA
|
|
Infections and infestations
Septicaemia staphylococcal
|
28.9%
13/45 • Number of events 14 • Through 36 weeks PMA
|
27.7%
13/47 • Number of events 14 • Through 36 weeks PMA
|
31.8%
14/44 • Number of events 15 • Through 36 weeks PMA
|
|
Infections and infestations
Tracheitis NOS
|
4.4%
2/45 • Number of events 2 • Through 36 weeks PMA
|
10.6%
5/47 • Number of events 8 • Through 36 weeks PMA
|
6.8%
3/44 • Number of events 5 • Through 36 weeks PMA
|
|
Infections and infestations
Urinary tract infection fungal
|
0.00%
0/45 • Through 36 weeks PMA
|
6.4%
3/47 • Number of events 3 • Through 36 weeks PMA
|
0.00%
0/44 • Through 36 weeks PMA
|
|
Injury, poisoning and procedural complications
Abrasion NOS
|
4.4%
2/45 • Number of events 2 • Through 36 weeks PMA
|
6.4%
3/47 • Number of events 3 • Through 36 weeks PMA
|
13.6%
6/44 • Number of events 6 • Through 36 weeks PMA
|
|
Investigations
Blood in stool
|
6.7%
3/45 • Number of events 3 • Through 36 weeks PMA
|
2.1%
1/47 • Number of events 1 • Through 36 weeks PMA
|
6.8%
3/44 • Number of events 3 • Through 36 weeks PMA
|
|
Investigations
Oxygen saturation decreased
|
37.8%
17/45 • Number of events 42 • Through 36 weeks PMA
|
38.3%
18/47 • Number of events 40 • Through 36 weeks PMA
|
36.4%
16/44 • Number of events 22 • Through 36 weeks PMA
|
|
Metabolism and nutrition disorders
Acidosis NOS
|
6.7%
3/45 • Number of events 3 • Through 36 weeks PMA
|
0.00%
0/47 • Through 36 weeks PMA
|
6.8%
3/44 • Number of events 3 • Through 36 weeks PMA
|
|
Metabolism and nutrition disorders
Hyperglycaemia NOS
|
22.2%
10/45 • Number of events 11 • Through 36 weeks PMA
|
19.1%
9/47 • Number of events 11 • Through 36 weeks PMA
|
15.9%
7/44 • Number of events 7 • Through 36 weeks PMA
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/45 • Through 36 weeks PMA
|
6.4%
3/47 • Number of events 3 • Through 36 weeks PMA
|
2.3%
1/44 • Number of events 1 • Through 36 weeks PMA
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
11.1%
5/45 • Number of events 5 • Through 36 weeks PMA
|
0.00%
0/47 • Through 36 weeks PMA
|
6.8%
3/44 • Number of events 3 • Through 36 weeks PMA
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.2%
1/45 • Number of events 1 • Through 36 weeks PMA
|
0.00%
0/47 • Through 36 weeks PMA
|
9.1%
4/44 • Number of events 4 • Through 36 weeks PMA
|
|
Metabolism and nutrition disorders
Hypoglycaemia neonatal
|
0.00%
0/45 • Through 36 weeks PMA
|
6.4%
3/47 • Number of events 3 • Through 36 weeks PMA
|
4.5%
2/44 • Number of events 2 • Through 36 weeks PMA
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.7%
3/45 • Number of events 5 • Through 36 weeks PMA
|
6.4%
3/47 • Number of events 3 • Through 36 weeks PMA
|
11.4%
5/44 • Number of events 5 • Through 36 weeks PMA
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
24.4%
11/45 • Number of events 14 • Through 36 weeks PMA
|
31.9%
15/47 • Number of events 19 • Through 36 weeks PMA
|
29.5%
13/44 • Number of events 15 • Through 36 weeks PMA
|
|
Metabolism and nutrition disorders
Metabolic acidosis NOS
|
8.9%
4/45 • Number of events 4 • Through 36 weeks PMA
|
19.1%
9/47 • Number of events 11 • Through 36 weeks PMA
|
20.5%
9/44 • Number of events 9 • Through 36 weeks PMA
|
|
Metabolism and nutrition disorders
Osteopenia
|
6.7%
3/45 • Number of events 3 • Through 36 weeks PMA
|
2.1%
1/47 • Number of events 1 • Through 36 weeks PMA
|
6.8%
3/44 • Number of events 3 • Through 36 weeks PMA
|
|
Nervous system disorders
Convulsions NOS
|
8.9%
4/45 • Number of events 4 • Through 36 weeks PMA
|
12.8%
6/47 • Number of events 6 • Through 36 weeks PMA
|
18.2%
8/44 • Number of events 10 • Through 36 weeks PMA
|
|
Nervous system disorders
Neurological disorder NOS
|
11.1%
5/45 • Number of events 5 • Through 36 weeks PMA
|
6.4%
3/47 • Number of events 3 • Through 36 weeks PMA
|
4.5%
2/44 • Number of events 2 • Through 36 weeks PMA
|
|
Renal and urinary disorders
Renal failure neonatal
|
4.4%
2/45 • Number of events 2 • Through 36 weeks PMA
|
17.0%
8/47 • Number of events 8 • Through 36 weeks PMA
|
13.6%
6/44 • Number of events 6 • Through 36 weeks PMA
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
2.2%
1/45 • Number of events 1 • Through 36 weeks PMA
|
10.6%
5/47 • Number of events 7 • Through 36 weeks PMA
|
6.8%
3/44 • Number of events 3 • Through 36 weeks PMA
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis neonatal
|
6.7%
3/45 • Number of events 3 • Through 36 weeks PMA
|
8.5%
4/47 • Number of events 4 • Through 36 weeks PMA
|
6.8%
3/44 • Number of events 3 • Through 36 weeks PMA
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dysplasia
|
86.7%
39/45 • Number of events 39 • Through 36 weeks PMA
|
72.3%
34/47 • Number of events 36 • Through 36 weeks PMA
|
84.1%
37/44 • Number of events 38 • Through 36 weeks PMA
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
8.9%
4/45 • Number of events 6 • Through 36 weeks PMA
|
12.8%
6/47 • Number of events 9 • Through 36 weeks PMA
|
6.8%
3/44 • Number of events 3 • Through 36 weeks PMA
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
13.3%
6/45 • Number of events 13 • Through 36 weeks PMA
|
8.5%
4/47 • Number of events 5 • Through 36 weeks PMA
|
4.5%
2/44 • Number of events 2 • Through 36 weeks PMA
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal apnoeic attack
|
33.3%
15/45 • Number of events 16 • Through 36 weeks PMA
|
38.3%
18/47 • Number of events 20 • Through 36 weeks PMA
|
31.8%
14/44 • Number of events 16 • Through 36 weeks PMA
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal hypoxia
|
40.0%
18/45 • Number of events 41 • Through 36 weeks PMA
|
53.2%
25/47 • Number of events 75 • Through 36 weeks PMA
|
15.9%
7/44 • Number of events 10 • Through 36 weeks PMA
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory acidosis
|
6.7%
3/45 • Number of events 4 • Through 36 weeks PMA
|
10.6%
5/47 • Number of events 5 • Through 36 weeks PMA
|
4.5%
2/44 • Number of events 2 • Through 36 weeks PMA
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory failure
|
15.6%
7/45 • Number of events 8 • Through 36 weeks PMA
|
2.1%
1/47 • Number of events 1 • Through 36 weeks PMA
|
4.5%
2/44 • Number of events 2 • Through 36 weeks PMA
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax NOS
|
11.1%
5/45 • Number of events 7 • Through 36 weeks PMA
|
14.9%
7/47 • Number of events 7 • Through 36 weeks PMA
|
6.8%
3/44 • Number of events 3 • Through 36 weeks PMA
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
4.4%
2/45 • Number of events 3 • Through 36 weeks PMA
|
2.1%
1/47 • Number of events 1 • Through 36 weeks PMA
|
13.6%
6/44 • Number of events 6 • Through 36 weeks PMA
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary interstitial emphysema syndrome
|
6.7%
3/45 • Number of events 3 • Through 36 weeks PMA
|
12.8%
6/47 • Number of events 6 • Through 36 weeks PMA
|
15.9%
7/44 • Number of events 7 • Through 36 weeks PMA
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
2.2%
1/45 • Number of events 3 • Through 36 weeks PMA
|
2.1%
1/47 • Number of events 2 • Through 36 weeks PMA
|
6.8%
3/44 • Number of events 3 • Through 36 weeks PMA
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure (exc neonatal)
|
8.9%
4/45 • Number of events 4 • Through 36 weeks PMA
|
8.5%
4/47 • Number of events 4 • Through 36 weeks PMA
|
9.1%
4/44 • Number of events 4 • Through 36 weeks PMA
|
|
Surgical and medical procedures
Patent ductus arteriosus repair
|
17.8%
8/45 • Number of events 8 • Through 36 weeks PMA
|
17.0%
8/47 • Number of events 8 • Through 36 weeks PMA
|
18.2%
8/44 • Number of events 8 • Through 36 weeks PMA
|
|
Vascular disorders
Hypertension neonatal
|
6.7%
3/45 • Number of events 3 • Through 36 weeks PMA
|
2.1%
1/47 • Number of events 1 • Through 36 weeks PMA
|
0.00%
0/44 • Through 36 weeks PMA
|
|
Vascular disorders
Intraventricular haemorrhage neonatal
|
37.8%
17/45 • Number of events 18 • Through 36 weeks PMA
|
53.2%
25/47 • Number of events 26 • Through 36 weeks PMA
|
38.6%
17/44 • Number of events 19 • Through 36 weeks PMA
|
|
Vascular disorders
Neonatal hypotension
|
11.1%
5/45 • Number of events 5 • Through 36 weeks PMA
|
17.0%
8/47 • Number of events 8 • Through 36 weeks PMA
|
11.4%
5/44 • Number of events 5 • Through 36 weeks PMA
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place