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

RecruitingPhase 3Ages 1 Hour - 24 HoursAllAerogen Pharma Limited
NCT06776783 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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 congenital/chromosomal anomaly (e.g., Pierre Robin syndrome, clinically significant 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 gas is not required prior to randomization. 11. 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. 12. Triplet or higher order multiple birth
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What it tests

  • APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system)
  • Control
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Where

31 sites
University of Arkansas for Medical Sciences
Little Rock, United States
Jacobs Medical Center
La Jolla, United States
University of California Davis Children's Hospital
Sacramento, United States
Sharp Mary Birch Hospital for Women & Newborns
San Diego, United States
UF Health Jacksonville
Jacksonville, United States
Advent Health
Orlando, United States
Memorial Hospital of South Bend
South Bend, United States
University of Maryland Children's Hospital
Baltimore, United States

…and 23 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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