InfasurfAero™ Versus Sham Treatment in Preterm Newborns with RDS

Eligibility Criteria

• 1. Written informed consent obtained by parent or legal representative prior to or after birth
• 2. Gestational age at birth ≥ 29 0/7 AND ≤ 35 6/7 weeks
• 3. Birthweight ≥ 1,000 AND ≤ 3,500 grams
• 4. Age ≥ 1 hour AND ≤ 6 hours
• 5. Clinical diagnosis of surfactant-deficient RDS, with EITHER i. a Silverman-Anderson Retraction Score ≥ 5 (in Room Air), OR ii. signs of respiratory distress (tachypnea, retractions, grunting) AND radiographic confirmation
• 6. Require CPAP
• 7. Respiratory Severity Score (RSS) ≥ 1.25 AND ≤ 2.4
• 8. If subject is \>346/7 weeks' gestation a chest radiograph is required
• 1. Surfactant administration prior to randomization
• 2. Mechanical ventilation prior to randomization
• 3. Major congenital anomaly (suspected or confirmed)
• 4. Abnormality of the airway (suspected or confirmed)
• 5. Respiratory distress presumed secondary to an etiology other than RDS (e.g., suspected pulmonary hypoplasia, pneumothorax, meconium aspiration syndrome, pneumonia, septic or hypovolemia shock, hypoxic ischemic encephalopathy)
• 6. Apgar score \< 3 at 5 minutes of age
• 7. Umbilical cord gas pH \<7.0 or BD \> 10
• 8. Any condition that, in the opinion of the Investigator, would place the neonate at undue risk