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

Windtree Therapeutics

Status and phase: Terminated; Phase 2

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

Treatments: Drug: Lucinactant 90 mg/kg; Drug: Placebo; Drug: Lucinactant 175 mg/kg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00215540

KL4-BPD-01

Details and patient eligibility

About

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).

Full 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).

Enrollment: 136 patients

Sex: All

Ages: 3 to 10 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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136 participants in 3 patient groups, including a placebo group

SURFAXIN High Dose

Experimental group

Description:

SURFAXIN (lucinactant) at 175 mg/kg

Treatment:

Drug: Lucinactant 175 mg/kg

SURFAXIN Low Dose

Experimental group

Description:

SURFAXIN (lucinactant) at 90 mg/kg

Treatment:

Drug: Lucinactant 90 mg/kg

Placebo

Placebo Comparator group

Description:

Sham air using 3.0 mL/kg volume of air

Treatment:

Drug: Placebo