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

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Efficacy of SURFAXIN® (Lucinactant), in Very Low Birth Weight (VLBW) Infants at Risk for Developing Bronchopulmonary Dysplasia

Conditions
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Respiratory Distress Syndrome, Newborn, Premature Birth, Bronchopulmonary Dysplasia

Intervention / Treatment
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* Drug: Lucinactant 175 mg/kg
* Drug: Lucinactant 90 mg/kg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Days
Maximum Age: 10 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SURFAXIN High Dose<br>SURFAXIN (lucinactant) at 175 mg/kg | Drug: Lucinactant 175 mg/kg<br>* Administered via slow intra-tracheal instillation at a dose of 175 mg/kg (5.8 mL/kg of a 30-mg/mL suspension). Initial treatment given no later than 1 hour after randomization. Additional treatments were administered every 48 hours up to a maximum of 5 doses (up to day of life (DOL) 18).<br>* Other names: Surfactant;|
| Experimental: SURFAXIN Low Dose<br>SURFAXIN (lucinactant) at 90 mg/kg | Drug: Lucinactant 90 mg/kg<br>* Administered via slow intra-tracheal instillation at a dose of 90 mg/kg (3.0 mL/kg of a 30-mg/mL suspension). Initial treatment given no later than 1 hour after randomization. Additional treatments were administered every 48 hours up to a maximum of 5 doses (up to DOL 18).<br>* Other names: Surfactant;|
| Placebo Comparator: Placebo<br>Sham air using 3.0 mL/kg volume of air | Drug: Placebo<br>* Sham air was administered via slow intratracheal instillation at a dose of 3.0 mL/kg volume of air. The initial treatment was given no later than 1 hour after randomization. Additional treatment were administered every 48 hours up to a maximum of 5 doses (up to DOL 18).<br>* Other names: Sham Air;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Double-blind, Low Birth Weight, Surfactant, Placebo-Controlled, Premature Birth