InfasurfAero™ Versus Sham Treatment in Preterm Newborns with RDS

Inclusion Criteria:

Inclusion criteria include ALL of the following:

1. Written informed consent obtained by parent or legal representative prior to orafter 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-AndersonRetraction 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

Exclusion Criteria:

Exclusion criteria are ANY of the following:

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 atundue risk