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Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome
Sponsor: Aerogen Pharma Limited
Summary
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.
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
Key Details
Gender
All
Age Range
1 Hour - 24 Hours
Study Type
INTERVENTIONAL
Enrollment
520
Start Date
2025-09-24
Completion Date
2029-05
Last Updated
2026-10-13
Healthy Volunteers
No
Interventions
APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system)
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
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.
Locations (31)
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