A Partially-Blind, Randomized, Parallel-Group Dose Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFactTM (Aerosolized SF-RI 1) Administered by nCPAP versus nCPAP alone in the Treatment of Preterm Infants at Risk for Worsening Respiratory Distress Syndrome
A Partially-Blind, Randomized, Controlled, Parallel-Group Dose Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFactTM (SF-RI 1 surfactant for inhalation combined with a dedicated drug delivery system) in Preterm Infants at Risk of Worsening Respiratory Distress Syndrome. To determine an optimal dose of AeroFact™ administered to preterm infants on nCPAP or nIMV vs. nCPAP or nIMV alone in reducing the incidence of intubation/cannulation and bolus surfactant instillation in the first 7 days after birth. To evaluate pulmonary outcomes and respiratory resource utilization at 3, 6, 9, and 12 months PMA
• Parental consent obtained prior to study procedures being performed (pre-natal consent is allowed)
• 26 0/7 to 30 6/7 weeks of gestational age
• Weight <2.0 Kg
• Respiratory Severity Score (RSS) 1.4-2.0
• Apgar score less than or equal to 5 at five minutes after birth
• Need for chest compressions or administration of epinephrine or bicarbonate in the delivery room
• Premature rupture of membranes (PROM) > 14 days
• Need for intubation and/or mechanical ventilation prior to enrollment
• Active pneumothorax requiring chest tube
• Significant congenital anomaly, chromosomal abnormality
• Concomitant treatments with inhaled nitric oxide
Drug: AeroFact, Other: nCPAP
Respiratory Distress Syndrome in Premature Infant
Respiratory Distress Syndrome, BPD, surfactant, Preterm Infant