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RECRUITING
NCT06776783
PHASE3

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

Sponsor: Aerogen Pharma Limited

View on ClinicalTrials.gov

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

2026-02-13

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

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.

OTHER

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 (9)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 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

Goryeb Children's Hospital

Morristown, New Jersey, United States

Montefiore Medical Center

The Bronx, New York, United States

Christus Children's Hospital

San Antonio, Texas, United States

University of Virginia School of Medicine

Charlottesville, Virginia, United States

WVU Medicine Children's Hospital

Morgantown, West Virginia, United States