RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Aerogen Pharma Limited • ClinicalTrials.gov ID: NCT06776783

Registry updated: 2026-10-13

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Description

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.

Interventions

APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system) (Combination product)
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.
Control (Other)
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.

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 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

Conditions

Respiratory Distress Syndrome Pre-term Infants

Locations

University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
Jacobs Medical Center — La Jolla, California, United States
University of California Davis Children's Hospital — Sacramento, California, United States
Sharp Mary Birch Hospital for Women & Newborns — San Diego, California, United States
UF Health Jacksonville — Jacksonville, Florida, United States
Advent Health — Orlando, Florida, United States
Memorial Hospital of South Bend — South Bend, Indiana, United States
University of Maryland Children's Hospital — Baltimore, Maryland, United States
Tufts Medical Center — Boston, Massachusetts, United States
Goryeb Children's Hospital — Morristown, New Jersey, United States
Mount Sinai Hospital — New York, New York, United States
The Trustees of Columbia University in the City of New York — New York, New York, United States
Montefiore Medical Center — The Bronx, New York, United States
Maria Farreri Children's Hospital — Valhalla, New York, United States
University of Pittsburgh Medical Center Magee Women's Hospital — Pittsburgh, Pennsylvania, United States
Christus Children's Hospital — San Antonio, Texas, United States
University of Virginia Children's Hospital — Charlottesville, Virginia, United States
WVU Medicine Children's Hospital — Morgantown, West Virginia, United States
Royal Alexandria Hospital — Edmonton, Alberta, Canada
IWK Health Centre — Halifax, Nova Scotia, Canada
McMaster Children's Hospital — Hamilton, Ontario, Canada
The Ottawa Hospital — Ottawa, Ontario, Canada
Mount Sinai Hospital Toronto — Toronto, Ontario, Canada
CHU de Québec-Université Laval — Québec, Quebec, Canada
Royal Jubilee Maternity Hospital — Belfast, United Kingdom
The Royal London Hospital — London, United Kingdom
Whipps Cross University Hospital — London, United Kingdom
Newham University Hospital — London, United Kingdom
University College Hospital — London, United Kingdom
Royal Preston Hospital — Preston, United Kingdom
Princess Royal Hospital — Telford, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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