SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants.

Phase 2

Terminated

Conditions: Respiratory Distress Syndrome, Newborn
Premature Birth
Bronchopulmonary Dysplasia

Interventions: Drug: Lucinactant 175 mg/kg
Drug: Lucinactant 90 mg/kg
Drug: Placebo

Brief Summary: SURFAXIN® (lucinactant) treatment will be examined in very low birth weight infants to prevent development of chronic lung disease, commonly known as bronchopulmonary dysplasia (BPD), in premature infants who have required continued intubation and received surfactants for the prevention or treatment of respiratory distress syndrome (RDS).

Detailed Description: Determine the safety and tolerability of SURFAXIN administration in the first weeks of life as a therapeutic approach for prevention of BPD. Determine whether treatment with SURFAXIN during the first two to three weeks of life can decrease the proportion of infants on mechanical ventilation or oxygen or the incidence of death or BPD in VLBW infants when assessed at 28 days of life and 36 weeks post-menstrual age (as determined by the need for supplemental oxygen).

Recruitment & Eligibility

Inclusion Criteria

Premature infants between 600 and 900 grams birth weight
Intubated and on mechanical ventilation
Sustained (>= 30 minutes) fraction of inspired oxygen (FiO₂) >= 0.30 within 8 hours prior to randomization

Exclusion Criteria

Mother has prolonged rupture of membranes ≥ 2 weeks
Culture-proven sepsis
High grade intraventricular hemorrhage (IVH)
Congenital heart disease
Congential anomalies inconsistent with life or likely to confound efficacy or safety endpoints
FiO₂≥ 0.80 and mean airway pressure (MAP) ≥ 12 cmH2O at day of life (DOL) 3
FiO₂< 0.25 at any time between meeting the entry criteria to immediately prior to randomization
Concomitant use of any other surfactant within the first 48 hours of life
Prior use of nitric oxide
Prior use of steroids
Current participation in any other clinical trial or has received an experimental drug or used an experimental device

Arm && Interventions

Group	Intervention	Description
SURFAXIN High Dose	Lucinactant 175 mg/kg	SURFAXIN (lucinactant) at 175 mg/kg
SURFAXIN Low Dose	Lucinactant 90 mg/kg	SURFAXIN (lucinactant) at 90 mg/kg
Placebo	Placebo	Sham air using 3.0 mL/kg volume of air

Primary Outcome Measures

Name	Time	Method
Incidence of Death or Bronchopulmonary Dysplasia (BPD) at 36 Weeks	36 weeks post-menstrual age (PMA)	Number of participants who died or developed BPD, defined as oxygen requirement at 36 Weeks post-menstrual age
All-cause Mortality	36 weeks PMA

Secondary Outcome Measures

Name	Time	Method
BPD at 28 Days	28 days of life	BPD at 28 days of life, as determined by the need for supplemental oxygen
BPD at 36 Weeks	36 weeks PMA	BPD at 36 weeks PMA as determined by the need for supplemental oxygen
Days Receiving Mechanical Ventilation (MV)	36 weeks PMA	Number of days receiving mechanical ventilation
Duration of Supplemental Oxygen	36 weeks PMA	Number of days receiving supplemental oxygen through 36 weeks PMA
Area Under the Curve for Fraction of Inspired Oxygen (FiO₂)	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 28	AUC for FiO₂calculated using the trapezoidal rule. Missing data imputed using last observation carried forward
Area Under the Curve for Mean Arterial Pressure (MAP)	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 28	AUC for MAP (in mm Hg) calculated using the trapezoidal rule. Missing data imputed using last observation carried forward
Incidence of Death or BPD at 28 Days	28 days of life	Death or BPD, defined as oxygen requirement at 28 days of life
Days in Hospital	36 weeks PMA	The number of days spent in the hospital through 36 weeks PMA