APC-0101 with noninvasive breathing support for preterm infants with respiratory distress syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-part, prospective, randomized, blinded, sham-controlled, multicenter Phase 3 study comparing inhaled APC-0101 plus noninvasive respiratory support (nCPAP/NIV) to nCPAP/NIV with a sham delivery. APC-0101 consists of an inhaled surfactant formulation delivered via a dedicated device and is given to eligible preterm infants soon after birth; the control group receives standard nCPAP/NIV without active surfactant. In Part 1 infants are followed until 40 weeks post-menstrual age or NICU discharge, and in Part 2 selected infants undergo follow-up through 24 months corrected age to capture longer-term outcomes. Randomization occurs within 1–24 hours of life for inborn infants of 26–33 weeks gestation who meet respiratory support and imaging criteria.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Arkansas for Medical Sciences
  Little Rock, Arkansas, United States Recruiting
• Jacobs Medical Center
  La Jolla, California, United States Recruiting
• University of California Davis Children's Hospital
  Sacramento, California, United States Recruiting
• Sharp Mary Birch Hospital for Women & Newborns
  San Diego, California, United States Recruiting
• UF Health Jacksonville
  Jacksonville, Florida, United States Recruiting
• Advent Health
  Orlando, Florida, United States Recruiting

Study contacts

• Study coordinator: Medical Director
• Email: AF3inquiries@aerogenpharma.com
• Phone: 9196026411

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.