Trial Outcomes & Findings for Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants (NCT NCT00767039)

NCT ID: NCT00767039

Last Updated: 2011-10-03

Results Overview

Mean Airway Pressure delivered by mechanical ventilator or nasal CPAP (cm H20) at 48 hours following surfactant administration. A volume cycle ventilator strategy that allowed airway pressure to vary with changes in lung and chest wall compliance was used for mechanically ventilated infants, while inspired oxygen concentration was controlled by the clinical team.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 52 participants
• Primary outcome timeframe: 48 hours after surfactant administration
• Results posted on: 2011-10-03

Participant Flow

Patients born between 1/2005 and 5/2008 with respiratory distress syndrome requiring mechanical ventilation, <30 weeks gestation, greater than 500 g and whose parents provided informed consent were included in the study. Infants with multiple congenital anomalies, significant congenital heart disease were excluded.

Participant milestones

Measure	Beractant Arm Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)	Poractant Alfa Arm Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
Overall Study STARTED	27	25
Overall Study COMPLETED	22	23
Overall Study NOT COMPLETED	5	2

Reasons for withdrawal

Measure	Beractant Arm Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)	Poractant Alfa Arm Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
Overall Study Death	5	2

Baseline Characteristics

Curosurf and Survanta Treatment(CAST)of RDS in Very Premature Infants

Baseline characteristics by cohort

Measure	Beractant Arm n=27 Participants Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)	Poractant Alfa Arm n=25 Participants Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)	Total n=52 Participants Total of all reporting groups
Age, Categorical <=18 years	27 Participants n=5 Participants	25 Participants n=7 Participants	52 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	13 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	12 Participants n=7 Participants	32 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	25 participants n=7 Participants	52 participants n=5 Participants
Gestational Age in weeks	26.7 weeks STANDARD_DEVIATION 1.7 • n=5 Participants	27.1 weeks STANDARD_DEVIATION 1.6 • n=7 Participants	26.9 weeks STANDARD_DEVIATION 1.6 • n=5 Participants

PRIMARY outcome

Timeframe: 48 hours after surfactant administration

Population: Enrolled subjects surviving \>/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.

Mean Airway Pressure delivered by mechanical ventilator or nasal CPAP (cm H20) at 48 hours following surfactant administration. A volume cycle ventilator strategy that allowed airway pressure to vary with changes in lung and chest wall compliance was used for mechanically ventilated infants, while inspired oxygen concentration was controlled by the clinical team.

Outcome measures

Measure	Beractant Arm n=25 Participants Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)	Poractant Alfa Arm n=25 Participants Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
Comparison Respiratory Support (Mean Airway Pressure) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration.	8.6 cm H20 Standard Error 0.8	6.4 cm H20 Standard Error 0.4

PRIMARY outcome

Timeframe: 72 hours after surfactant administration

Population: Enrolled subjects surviving \>/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.

Mean Airway Pressure delivered by mechanical ventilator or nasal CPAP (cm H20) at 72 hours following surfactant administration. A volume cycle ventilator strategy that allowed airway pressure to vary with changes in lung and chest wall compliance was used for mechanically ventilated infants, while oxygen concentration was controlled by the clinical team.

Outcome measures

Measure	Beractant Arm n=25 Participants Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)	Poractant Alfa Arm n=25 Participants Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
Comparison of Respiratory Support (Mean Airway Pressure) for Curosurf (Poractant) and Survanta (Beractant) 72 Hours After Surfactant Administration	7.9 cm H20 Standard Error 0.6	6.0 cm H20 Standard Error 0.7

PRIMARY outcome

Timeframe: 48 hours after surfactant administration

Population: Enrolled subjects surviving \>/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.

Mean Airway Pressure x Percent Fraction of Inspired Oxygen (FIO2) at 48 hours after surfactant administration, delivered by mechanical ventilator or nasal CPAP assesses the components of respiratory support primarily affecting blood oxygenation. This index combines these parameters so that a systematic difference in clinical management of mean airway pressure or FIO2 between groups is not mistaken for a drug effect.

Outcome measures

Measure	Beractant Arm n=25 Participants Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)	Poractant Alfa Arm n=25 Participants Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 48 Hours After Surfactant Administration.	274 cm H20-Percent of O2 Standard Error 35	170 cm H20-Percent of O2 Standard Error 18

PRIMARY outcome

Timeframe: 72 hours after surfactant administration

Population: Enrolled subjects surviving \>/= 3 days were included in the analysis. Two subjects in the Survanta (beractant) groups died in this period and were eliminated from this portion of the analysis.

Mean Airway Pressure x Percent Fraction of Inspired Oxygen (FIO2) at 72 hours after surfactant administration, delivered by mechanical ventilator or nasal CPAP assesses the components of respiratory support primarily affecting blood oxygenation. This index combines these parameters so that a systematic difference in clinical management of mean airway pressure or FIO2 between groups is not mistaken for a drug effect.

Outcome measures

Measure	Beractant Arm n=25 Participants Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)	Poractant Alfa Arm n=25 Participants Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
Comparison Respiratory Support (Mean Airway Pressure x Percent Fraction of Inspired Oxygen) for Survanta (Beractant) and Curosurf (Poractant) at 72 Hours After Surfactant Administration.	226 cm H20-Percent of O2 Standard Error 29	140 cm H20-Percent of O2 Standard Error 16

SECONDARY outcome

Timeframe: 48 hours after surfactant administration

Population: Patients no longer needing positive pressure endotracheal mechanical ventilation were tallied to help explain the between group differences in mean airway pressure.

Subjects successfully extubated and no longer needing positive pressure endotracheal mechanical ventilation at 48 hours after surfactant administration helps to explain the difference in mean airway pressure observed between groups.

Outcome measures

Measure	Beractant Arm n=27 Participants Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)	Poractant Alfa Arm n=25 Participants Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
Comparison of Infants Successfully Extubated at 48 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups	6 Participants successfully extubated Interval 3.0 to 10.0	13 Participants successfully extubated Interval 9.0 to 17.0

SECONDARY outcome

Timeframe: 72 hours after surfactant administration

Population: Patients no longer needing positive pressure endotracheal mechanical ventilation were tallied to help explain the between group differences in mean airway pressure.

Subjects successfully extubated and no longer needing positive pressure endotracheal mechanical ventilation at 72 hours after surfactant administration helps to explain the difference in mean airway pressure observed between groups.

Outcome measures

Measure	Beractant Arm n=27 Participants Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)	Poractant Alfa Arm n=25 Participants Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
Comparison of Infants Successfully Extubated at 72 Hours for Curosurf (Poractant) and Survanta (Beractant) Groups	8 Participants successfully extubated Interval 5.0 to 12.0	15 Participants successfully extubated Interval 11.0 to 19.0

SECONDARY outcome

Timeframe: Hemodynamically significant PDA at > 2 days

Population: Patients with clinically and hemodynamically significant Patent Ductus Arteriosus, on evaluation at \>3 days, were tallied

Hemodynamically significant PDA, considered significant by the clinical team and having at least 2 objective echocardiographic signs (PDA > 1.5 mm diameter, retrograde diastolic flow in the descending aorta, and left atrial enlargement) were tallied. Hemodynamically significant PDA may increase lung water and decrease lung compliance, requiring increased mechanical ventilator support.

Outcome measures

Measure	Beractant Arm n=25 Participants Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)	Poractant Alfa Arm n=25 Participants Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
Comparison of Hemodynamically Significant Patent Ductus Arteriosus (PDA) in Patients Treated With Curosurf (Poractant) and Survanta (Beractant)	19 Subjects Interval 15.0 to 22.0	8 Subjects Interval 5.0 to 12.0

SECONDARY outcome

Timeframe: First hour after 2nd surfactant dose

Population: Population was limited to those subjects with PDA's who were treated with a second dose of surfactant, when the subjects were hemodynamically stable enough to yield meaning data.

Maximal changes in blood flow were assessed using Doppler echocardiography following the second surfactant dose of Survanta (beractant) or Curosurf (poractant alfa), to determine whether there was a direct effect of surfactant type on PDA size or pulmonary volume overload through the PDA. The hour interval following the second surfactant dose was selected for study, when the subjects were otherwise clinically stable, not needing additional stabilization procedures.

Outcome measures

Measure	Beractant Arm n=9 Participants Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)	Poractant Alfa Arm n=7 Participants Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
Changes in Blood Flow Through the Patent Ductus Arteriosus (PDA) Following Second Dose of Survanta (Beractant) and Poractant Alfa (Curosurf) Baseline PDA Flow, before surfactant (cc/min)	138 cc/min Standard Error 36	123 cc/min Standard Error 45
Changes in Blood Flow Through the Patent Ductus Arteriosus (PDA) Following Second Dose of Survanta (Beractant) and Poractant Alfa (Curosurf) Maximal PDA Flow, following surfactant (cc/min)	169 cc/min Standard Error 52	143 cc/min Standard Error 35
Changes in Blood Flow Through the Patent Ductus Arteriosus (PDA) Following Second Dose of Survanta (Beractant) and Poractant Alfa (Curosurf) Change in PDA Flow, following surfactant (cc/min)	32 cc/min Standard Error 42	20 cc/min Standard Error 37

SECONDARY outcome

Timeframe: One hour following second surfactant dose at 12-24 hours after initial dose

Population: The population analyzed was limited to subjects that received second dose of surfactant and were clinically stable enough to allow Doppler assessment of cerebral blood flow during the first hour following surfactant administration.

Percent change in Anterior Cerebral Artery blood flow velocity following the second dose of beractant, reflects the change in brain blood flow associated with surfactant administration. Blood flow velocity is measured by range gated Doppler ultrasound and brain blood flow changes in proportion to changes in arterial carbon dioxide levels, induced by surfactant administration. Variability in brain blood flow is associated with increased risk for intraventricular hemorrhage.

Outcome measures

Measure	Beractant Arm n=9 Participants Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)	Poractant Alfa Arm n=7 Participants Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
Change in Anterior Cerebral Artery Blood Flow Velocity Following Second Dose of Surfactant Percent Change in Blood Flow Velocity (%)	47.4 Percent change from baseline velocity Standard Error 11.9	-1.8 Percent change from baseline velocity Standard Error 14.6
Change in Anterior Cerebral Artery Blood Flow Velocity Following Second Dose of Surfactant Blood Flow Velocity, before surfactant (cm/sec)	12.5 Percent change from baseline velocity Standard Error 1.5	22.4 Percent change from baseline velocity Standard Error 2.8
Change in Anterior Cerebral Artery Blood Flow Velocity Following Second Dose of Surfactant Peak Blood Flow Velocity, post surfactant (cm/sec)	18.3 Percent change from baseline velocity Standard Error 2.4	20.4 Percent change from baseline velocity Standard Error 2.1
Change in Anterior Cerebral Artery Blood Flow Velocity Following Second Dose of Surfactant Peak Change in Blood Flow Velocity (cm/sec)	5.6 Percent change from baseline velocity Standard Error 1.3	-2.0 Percent change from baseline velocity Standard Error 3.1

SECONDARY outcome

Timeframe: 36 weeks post menstrual age

Population: Population analyzed was limited to those subjects who survived to \>36 weeks post menstrual age. Subjects with Bronchopulmonary Dysplasia (continuous supplemental oxygen need at \>36 weeks post menstrual age) were tallied.

Patients with Bronchopulmonary Dysplasia (BPD), had chronic lung disease requiring supplemental oxygen support at >/= 36 weeks post menstrual age, were tallied. BPD is a chronic lung disease that develops, at least in part, as a consequence of NICU respiratory management of premature infants with Respiratory Distress Syndrome.

Outcome measures

Measure	Beractant Arm n=22 Participants Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)	Poractant Alfa Arm n=23 Participants Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
Patients With Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age)	11 Surviving Subjects with BPD Interval 7.0 to 15.0	8 Surviving Subjects with BPD Interval 4.0 to 11.0

SECONDARY outcome

Timeframe: NICU hospitalization, up to 42 weeks post menstrual age

Population: All subjects enrolled were included. Subjects with Bronchopulmonary Dysplasia (continuous supplemental oxygen need at \> 36 weeks post menstrual age) and patients who expired before discharge from the NICU were tallied.

Bronchopulmonary Dysplasia + death outcome for all patients enrolled in the study were tallied and used to determine whether neonatal death decreased the frequency of chronic lung disease in one group vs the other.

Outcome measures

Measure	Beractant Arm n=27 Participants Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)	Poractant Alfa Arm n=25 Participants Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
Bronchopulmonary Dysplasia (Supplemental Oxygen at 36 Week Post Menstrual Age) or Death Before Discharge From NICU.	16 Subjects with BPD + Neonatal Deaths Interval 12.0 to 20.0	10 Subjects with BPD + Neonatal Deaths Interval 6.0 to 14.0

Adverse Events

Beractant Arm

Serious events: 19 serious events

Other events: 17 other events

Deaths: 0 deaths

Poractant Alfa Arm

Serious events: 9 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Beractant Arm n=27 participants at risk Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)	Poractant Alfa Arm n=25 participants at risk Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
General disorders Death	18.5% 5/27 • Number of events 5 • Adverse events occurring during the NICU admission, up to 42 weeks post menstrual age. Severe adverse evens include: severe intraventricular hemorrhage, severe pulmonary hemorrhage, Necrotizing enterocolitis, Threshold Retinopathy of prematurity requiring Laser therapy, or death	8.0% 2/25 • Number of events 2 • Adverse events occurring during the NICU admission, up to 42 weeks post menstrual age. Severe adverse evens include: severe intraventricular hemorrhage, severe pulmonary hemorrhage, Necrotizing enterocolitis, Threshold Retinopathy of prematurity requiring Laser therapy, or death
Gastrointestinal disorders Necrotizing Enterocolitis	14.8% 4/27 • Number of events 4 • Adverse events occurring during the NICU admission, up to 42 weeks post menstrual age. Severe adverse evens include: severe intraventricular hemorrhage, severe pulmonary hemorrhage, Necrotizing enterocolitis, Threshold Retinopathy of prematurity requiring Laser therapy, or death	16.0% 4/25 • Number of events 4 • Adverse events occurring during the NICU admission, up to 42 weeks post menstrual age. Severe adverse evens include: severe intraventricular hemorrhage, severe pulmonary hemorrhage, Necrotizing enterocolitis, Threshold Retinopathy of prematurity requiring Laser therapy, or death
Nervous system disorders Severe Intraventricular Hemorrahge (Grade 3-4)	3.7% 1/27 • Number of events 1 • Adverse events occurring during the NICU admission, up to 42 weeks post menstrual age. Severe adverse evens include: severe intraventricular hemorrhage, severe pulmonary hemorrhage, Necrotizing enterocolitis, Threshold Retinopathy of prematurity requiring Laser therapy, or death	4.0% 1/25 • Number of events 1 • Adverse events occurring during the NICU admission, up to 42 weeks post menstrual age. Severe adverse evens include: severe intraventricular hemorrhage, severe pulmonary hemorrhage, Necrotizing enterocolitis, Threshold Retinopathy of prematurity requiring Laser therapy, or death
Respiratory, thoracic and mediastinal disorders Significant Pulmonary Hemorrhage	11.1% 3/27 • Number of events 3 • Adverse events occurring during the NICU admission, up to 42 weeks post menstrual age. Severe adverse evens include: severe intraventricular hemorrhage, severe pulmonary hemorrhage, Necrotizing enterocolitis, Threshold Retinopathy of prematurity requiring Laser therapy, or death	4.0% 1/25 • Number of events 1 • Adverse events occurring during the NICU admission, up to 42 weeks post menstrual age. Severe adverse evens include: severe intraventricular hemorrhage, severe pulmonary hemorrhage, Necrotizing enterocolitis, Threshold Retinopathy of prematurity requiring Laser therapy, or death
Eye disorders ROP Stage II-IV	43.5% 10/23 • Number of events 10 • Adverse events occurring during the NICU admission, up to 42 weeks post menstrual age. Severe adverse evens include: severe intraventricular hemorrhage, severe pulmonary hemorrhage, Necrotizing enterocolitis, Threshold Retinopathy of prematurity requiring Laser therapy, or death	29.2% 7/24 • Number of events 7 • Adverse events occurring during the NICU admission, up to 42 weeks post menstrual age. Severe adverse evens include: severe intraventricular hemorrhage, severe pulmonary hemorrhage, Necrotizing enterocolitis, Threshold Retinopathy of prematurity requiring Laser therapy, or death

Other adverse events

Measure	Beractant Arm n=27 participants at risk Surfactant (beractant, Survanta), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (100 mg/kg initial and subsequent doses, up to 4 doses at 6-12 h intervals)	Poractant Alfa Arm n=25 participants at risk Surfactant (poractant, Curosurf), intratracheal administration to very premature infants with RDS requiring mechanical ventilation (initial dose 200 mg/kg, subsequent doses 100 mg/kg, up to 3 doses)
Respiratory, thoracic and mediastinal disorders Bronchopulmonary Dysplasia	50.0% 11/22 • Number of events 11 • Adverse events occurring during the NICU admission, up to 42 weeks post menstrual age. Severe adverse evens include: severe intraventricular hemorrhage, severe pulmonary hemorrhage, Necrotizing enterocolitis, Threshold Retinopathy of prematurity requiring Laser therapy, or death	34.8% 8/23 • Number of events 8 • Adverse events occurring during the NICU admission, up to 42 weeks post menstrual age. Severe adverse evens include: severe intraventricular hemorrhage, severe pulmonary hemorrhage, Necrotizing enterocolitis, Threshold Retinopathy of prematurity requiring Laser therapy, or death
Cardiac disorders Patent Ductus Arteriosus ligation	28.0% 7/25 • Number of events 7 • Adverse events occurring during the NICU admission, up to 42 weeks post menstrual age. Severe adverse evens include: severe intraventricular hemorrhage, severe pulmonary hemorrhage, Necrotizing enterocolitis, Threshold Retinopathy of prematurity requiring Laser therapy, or death	16.0% 4/25 • Number of events 4 • Adverse events occurring during the NICU admission, up to 42 weeks post menstrual age. Severe adverse evens include: severe intraventricular hemorrhage, severe pulmonary hemorrhage, Necrotizing enterocolitis, Threshold Retinopathy of prematurity requiring Laser therapy, or death
Respiratory, thoracic and mediastinal disorders Pulmonary Air Leak	14.8% 4/27 • Number of events 4 • Adverse events occurring during the NICU admission, up to 42 weeks post menstrual age. Severe adverse evens include: severe intraventricular hemorrhage, severe pulmonary hemorrhage, Necrotizing enterocolitis, Threshold Retinopathy of prematurity requiring Laser therapy, or death	0.00% 0/25 • Adverse events occurring during the NICU admission, up to 42 weeks post menstrual age. Severe adverse evens include: severe intraventricular hemorrhage, severe pulmonary hemorrhage, Necrotizing enterocolitis, Threshold Retinopathy of prematurity requiring Laser therapy, or death

Additional Information

Alan Fujii MD (PI)

Boston Medical Center

Phone: 617-4414-3735

Email: Alan.Fujii@bmc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60