Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome

Inclusion Criteria:

1. Inborn at the study site's hospital (i.e., not transferred from another hospitalfollowing delivery)

2. Gestational age at birth of 26 through 33 weeks PMA

3. Birth weight appropriate for gestational age (AGA, weight 3rd to 97th percentile onFenton Growth Curve)

4. Birth weight ≤ 2000 grams

5. Post-natal age 1 to 24 hours at randomization

6. On nCPAP or NIV for at least 30 minutes with RSS = 1.4 - 2.0 to maintain SpO2 90-95%at randomization. RSS is calculated as (nCPAP cm H2O) × (FiO2) or as (NIV meanairway pressure cm H2O) × (FiO2).

7. FiO2 ≥ 0.24 at randomization

8. nCPAP or mPaw ≥ 6 cm H2O at randomization

9. Chest radiograph (CXR) or lung ultrasound compatible with RDS prior to randomization

Exclusion Criteria:

1. On SiPAP®, RAM® cannula, or high flow nasal cannula (HFNC) (> 2 liters per minute [LPM]) at the time of randomization

2. Prior instillation of surfactant

3. Premature rupture of membranes (PROM) occurring > 14 days before birth

4. Significant congenital/chromosomal anomaly (e.g., Pierre Robin syndrome, clinicallysignificant congenital heart disease, or trisomy)

5. Pneumothorax

6. Other etiologies of respiratory distress

7. Enrollment in another interventional study with similar efficacy endpoints

8. Apgar score at 5 min of 0-3

9. Prior cardiopulmonary resuscitation (CPR) or epinephrine

10. Base Deficit > 15 mEq/L on most recent arterial blood gas (not capillary blood gas,venous blood gas, or cord gas) prior to randomization. Note that arterial blood gasis not required prior to randomization.

11. Partial pressure of carbon dioxide (PaCO2) > 65 mmHg on most recent arterial bloodgas (not capillary blood gas, venous blood gas, or cord gas) prior to randomization.

12. Triplet or higher order multiple birth