Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome (NCT06776783)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Arkansas for Medical Sciences — Little Rock, Arkansas
Age range: 1 Hour to 24 Hours
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (12 Sites)
- University of Arkansas for Medical Sciences — Little Rock, Arkansas
- Jacobs Medical Center — La Jolla, California
- UF Health Jacksonville — Jacksonville, Florida
- Advent Health — Orlando, Florida
- Memorial Hospital of South Bend — South Bend, Indiana
- Goryeb Children's Hospital — Morristown, New Jersey
- The Trustees of Columbia University in the City of New York — New York, New York
- Montefiore Medical Center — The Bronx, New York
- Maria Farreri Children's Hospital — Valhalla, New York
- Christus Children's Hospital — San Antonio, Texas
- University of Virginia School of Medicine — Charlottesville, Virginia
- WVU Medicine Children's Hospital — Morgantown, West Virginia
📞 Contact the Study Coordinator
Phone: (919) 602-6411
Email: AF3inquiries@aerogenpharma.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Respiratory Distress Syndrome
- Spinal Cord Stimulation to Shorten Ventilator Dependence in ARDS Patients — Los Angeles, California
- Non Inferiority Trial Investigating Surfactants Administered Via MIST — Evanston, Illinois
Explore by condition: All Respiratory Distress Syndrome clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.