A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact

Completed · Phase 2

Conditions studied: Respiratory Distress Syndrome in Premature Infant

In brief

The purpose of this two-part Phase 2 study is to assess the safety, tolerability and efficacy of aerosolized SF-RI 1 (AeroFact) when delivered via nCPAP at two different doses.

Key facts

Study ID

NCT03969992

Run by

Aerogen Pharma Limited

People needed

261

Starts

2020-03-04

Expected to finish

2024-08-05

Last updated by the study team

2025-08-07

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Parental consent obtained prior to study procedures being performed (pre-natal consent is allowed)
• 26 0/7 to 30 6/7 weeks of gestational age
• Weight <2.0 Kg
• Respiratory Severity Score (RSS) 1.4-2.0

You may not qualify if…

• Apgar score less than or equal to 5 at five minutes after birth
• Need for chest compressions or administration of epinephrine or bicarbonate in the delivery room
• Premature rupture of membranes (PROM) > 14 days
• Need for intubation and/or mechanical ventilation prior to enrollment
• Active pneumothorax requiring chest tube
• Significant congenital anomaly, chromosomal abnormality
• Concomitant treatments with inhaled nitric oxide

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Alta Bates Summit — Berkeley, California, United States
• Children's Hospital Orange County — Orange, California, United States
• University of Colorado — Aurora, Colorado, United States
• University of Florida Health — Jacksonville, Florida, United States
• Wolfson Children's Hospital — Jacksonville, Florida, United States
• South Miami Hospital — Miami, Florida, United States
• Advent Health — Orlando, Florida, United States
• Winnie Palmer Hospital — Orlando, Florida, United States
• Northside Hospital Atlanta — Atlanta, Georgia, United States
• University of Illinois — Chicago, Illinois, United States
• Hospital of South Bend — South Bend, Indiana, United States
• University of Louisville — Louisville, Kentucky, United States
• Barbara Bush Medical Center — Portland, Maine, United States
• University of Maryland — Baltimore, Maryland, United States
• Holy Cross Hospital — Silver Spring, Maryland, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Children's and Women's (C & W) Mott Hospital — Ann Arbor, Michigan, United States
• Children's Health Care d/b/a Children's Minnesota — Minneapolis, Minnesota, United States
• University of Minnesota Masonic Children's Hospital — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• University of Mississippi — Jackson, Mississippi, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Maimonides Hospital — Brooklyn, New York, United States
• Mount Sinai Kravis Children's Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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