Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome
Public ClinicalTrials.gov record NCT06776783. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06776783
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 520 participants
Conditions and interventions
Conditions
Interventions
- APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system) Combination Product
- Control Other
Combination Product · Other
Eligibility (public fields only)
- Age range
- 1 Hour to 24 Hours
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 23, 2025
- Primary completion
- Apr 30, 2027
- Completion
- Apr 30, 2029
- Last update posted
- Aug 5, 2026
2025 – 2029
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | Recruiting |
| Jacobs Medical Center | La Jolla | California | 92037 | Recruiting |
| UF Health Jacksonville | Jacksonville | Florida | 32209 | Recruiting |
| Advent Health | Orlando | Florida | 32803 | Recruiting |
| Memorial Hospital of South Bend | South Bend | Indiana | 46601 | Recruiting |
| Goryeb Children's Hospital | Morristown | New Jersey | 07960 | Recruiting |
| The Trustees of Columbia University in the City of New York | New York | New York | 10032 | Recruiting |
| Montefiore Medical Center | The Bronx | New York | 10461 | Recruiting |
| Maria Farreri Children's Hospital | Valhalla | New York | 10595 | Recruiting |
| Christus Children's Hospital | San Antonio | Texas | 78207 | Recruiting |
| University of Virginia School of Medicine | Charlottesville | Virginia | 22903 | Recruiting |
| WVU Medicine Children's Hospital | Morgantown | West Virginia | 26506 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06776783, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 5, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06776783 live on ClinicalTrials.gov.