SURFAXIN® Treatment for Prevention of Bronchopulmonary Dysplasia (BPD) in Very Low Birth Weight (VLBW) Infants.
Condition: Respiratory Distress Syndrome, Newborn; Premature Birth; Bronchopulmonary Dysplasia
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Bronchopulmonary Dysplasia; Premature Birth; Birth Weight
Intervention: Lucinactant 175 mg/kg; Lucinactant 90 mg/kg; Placebo
Intervention description: 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).; 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).; 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).
Intervention MeSH terms: Pulmonary Surfactants
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 136.0
Sex: All
Minimum age: 3 Days
Maximum age: 10 Days
Healthy volunteers: No
Keywords: Double-blind; Low Birth Weight; Surfactant; Placebo-Controlled; Premature Birth

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).
    

Eligibility criteria:

        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