A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact
NCT ID: NCT03969992
Last Updated: 2025-08-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
261 participants
INTERVENTIONAL
2020-03-04
2024-08-05
Brief Summary
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Detailed Description
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Part II Primary Objective To evaluate pulmonary outcomes and respiratory utilization at 3, 6, 9, and 12 months post-menstrual age (PMA)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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nCPAP alone
Standard of Care (nasal continuous positive airway pressure-nCPAP) with instilled bolus surfactant when medically necessary
nCPAP
nCPAP (nasal continuous positive airway pressure) alone
Drug: Low Dose AeroFact
AeroFact-low dose SF-RI 1
AeroFact
Aerosolized SF-RI 1
Drug: High Dose AeroFact
AeroFact-high dose SF-RI 1
AeroFact
Aerosolized SF-RI 1
Interventions
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AeroFact
Aerosolized SF-RI 1
nCPAP
nCPAP (nasal continuous positive airway pressure) alone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 26 0/7 to 30 6/7 weeks of gestational age
3. Weight \<2.0 Kg
4. Respiratory Severity Score (RSS) 1.4-2.0
Exclusion Criteria
2. Need for chest compressions or administration of epinephrine or bicarbonate in the delivery room
3. Premature rupture of membranes (PROM) \> 14 days
4. Need for intubation and/or mechanical ventilation prior to enrollment
5. Active pneumothorax requiring chest tube
6. Significant congenital anomaly, chromosomal abnormality
7. Concomitant treatments with inhaled nitric oxide
26 Weeks
31 Weeks
ALL
No
Sponsors
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Aerogen Pharma Limited
INDUSTRY
Responsible Party
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Principal Investigators
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David Durand, MD
Role: STUDY_DIRECTOR
Aerogen Pharma Corp
Locations
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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
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, United States
NY Presbyterian Morgan Stanley Children's Hospital-Columbia
New York, New York, United States
West Chester Medical Center-Maria Fareri Children's Hospital
Valhalla, New York, United States
Levine Children's Hospital
Charlotte, North Carolina, United States
Grant Hospital
Columbus, Ohio, United States
Texas Health-Methodist Harris
Fort Worth, Texas, United States
Women's Hospital of Texas
Houston, Texas, United States
Children's Hospital of San Antonio (CHofSA)
San Antonio, Texas, United States
Methodist Children's Hospital
San Antonio, Texas, United States
North Central Baptist Hospital
San Antonio, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
University of Washington
Seattle, Washington, United States
IWK Hospital
Halifax, Nova Scotia, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Mt. Sinai Hospital
Toronto, Ontario, Canada
CHU de Québec-Université Laval
Québec, Quebec, Canada
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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APC-AF-CLN-002
Identifier Type: -
Identifier Source: org_study_id
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