Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome
A Randomized, Controlled, Blinded, Parallel Group Study of the Safety and Efficacy of APC-0101 (SF-RI 1 Surfactant for Inhalation Combined With a Dedicated Delivery System) in Preterm Infants With Respiratory Distress Syndrome
Aerogen Pharma Limited
520 participants
Sep 24, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria9
- 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
- Chest radiograph (CXR) or lung ultrasound compatible with RDS prior to randomization
Exclusion Criteria12
- 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)
- Pneumothorax
- Other etiologies of respiratory distress
- Enrollment in another interventional study with similar efficacy endpoints
- Apgar score at 5 min of 0-3
- Prior cardiopulmonary resuscitation (CPR) or epinephrine
- 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 gas is not required prior to randomization.
- Partial pressure of carbon dioxide (PaCO2) > 65 mmHg on most recent arterial blood gas (not capillary blood gas, venous blood gas, or cord gas) prior to randomization.
- Triplet or higher order multiple birth
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Interventions
Subjects in the APC-0101 group will be changed from their current nCPAP/NIV interface to the APC-0101 nCPAP/NIV interface and APC-0101 treatment will be started.
Subjects in the Control group will be changed from their current nCPAP/NIV interface to the APC-0101 nCPAP/NIV interface but an empty vial will be used instead of APC-0101.
Locations(12)
View Full Details on ClinicalTrials.gov
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NCT06776783