Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome (NCT06776783) | Clinical Trial Compass
RecruitingPhase 3
Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome
United States520 participantsStarted 2025-09-24
Plain-language 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.
Who can participate
Age range1 Hour – 24 Hours
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Inborn at the study site's hospital (i.e., not transferred from another hospital following delivery)
✓. Gestational age at birth of 26 through 33 weeks PMA
✓. Birth weight appropriate for gestational age (AGA, weight 3rd to 97th percentile on Fenton Growth Curve)
✓. Birth weight ≤ 2000 grams
✓. Post-natal age 1 to 24 hours at randomization
✓. 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).
✓. FiO2 ≥ 0.24 at randomization
✓. nCPAP or mPaw ≥ 6 cm H2O at randomization
Exclusion criteria
✕. On SiPAP®, RAM® cannula, or high flow nasal cannula (HFNC) (\> 2 liters per minute \[LPM\]) at the time of randomization
✕. Prior instillation of surfactant
✕. Premature rupture of membranes (PROM) occurring \> 14 days before birth
✕. Significant congenital/chromosomal anomaly (e.g., Pierre Robin syndrome, clinically significant congenital heart disease, or trisomy)