Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome
Trial Parameters
Brief Summary
This is a 2-part, prospective, randomized, blinded, sham-controlled, multi-center study comparing preterm subjects with RDS who are treated with APC-0101 and nCPAP/NIV to subjects treated with nCPAP/NIV alone (Sham). In Part 1, subjects will be followed until they reach 40 weeks post-menstrual age (PMA) or are discharged from the NICU, whichever comes first. In Part 2, subjects will undergo post-term follow-up through 24 months corrected age.
Eligibility Criteria
Inclusion Criteria: 1. Inborn at the study site's hospital (i.e., not transferred from another hospital following 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 on Fenton 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 mean airway 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