Actively Recruiting
Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome
Led by Aerogen Pharma Limited · Updated on 2026-04-14
520
Participants Needed
12
Research Sites
187 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Inborn at the study site's hospital (not transferred from another hospital following delivery)
- Gestational age at birth between 26 and 33 weeks post-menstrual age
- Birth weight appropriate for gestational age (3rd to 97th percentile on Fenton Growth Curve)
- Birth weight less than or equal to 2000 grams
- Post-natal age between 1 and 24 hours at randomization
- Receiving nCPAP or NIV for at least 30 minutes with respiratory severity score between 1.4 and 2.0 to maintain oxygen saturation 90-95% at randomization
- Fraction of inspired oxygen (FiO2) at least 0.24 at randomization
- nCPAP or mean airway pressure at least 6 cm H2O at randomization
- Chest X-ray or lung ultrasound compatible with respiratory distress syndrome before randomization
You will not qualify if you...
- Receiving SiPAP, RAM cannula, or high flow nasal cannula over 2 liters per minute at randomization
- Prior surfactant treatment
- Premature rupture of membranes more than 14 days before birth
- Significant congenital or chromosomal anomalies such as Pierre Robin syndrome, clinically significant heart disease, or trisomy
- Pneumothorax
- Other causes of respiratory distress
- Enrolled in another interventional study with similar efficacy endpoints
- Apgar score of 0 to 3 at 5 minutes
- Prior cardiopulmonary resuscitation or epinephrine use
- Base deficit greater than 15 mEq/L on most recent arterial blood gas before randomization
- Partial pressure of carbon dioxide greater than 65 mmHg on most recent arterial blood gas before randomization
- Triplet or higher order multiple births
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 12 locations
1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Actively Recruiting
2
Jacobs Medical Center
La Jolla, California, United States, 92037
Actively Recruiting
3
UF Health Jacksonville
Jacksonville, Florida, United States, 32209
Actively Recruiting
4
Advent Health
Orlando, Florida, United States, 32803
Actively Recruiting
5
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Actively Recruiting
6
Goryeb Children's Hospital
Morristown, New Jersey, United States, 07960
Actively Recruiting
7
The Trustees of Columbia University in the City of New York
New York, New York, United States, 10032
Actively Recruiting
8
Montefiore Medical Center
The Bronx, New York, United States, 10461
Actively Recruiting
9
Maria Farreri Children's Hospital
Valhalla, New York, United States, 10595
Actively Recruiting
10
Christus Children's Hospital
San Antonio, Texas, United States, 78207
Actively Recruiting
11
University of Virginia School of Medicine
Charlottesville, Virginia, United States, 22903
Actively Recruiting
12
WVU Medicine Children's Hospital
Morgantown, West Virginia, United States, 26506
Actively Recruiting
Research Team
S
Shannon Strom
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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