A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact
Public ClinicalTrials.gov record NCT03969992. 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 Partially Blinded, Randomized, Controlled, Parallel-Group, Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact in Preterm Infants at Risk of Worsening Respiratory Distress Syndrome
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03969992
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 261 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 26 Weeks to 31 Weeks
- 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
- Mar 4, 2020 (Actual)
- Primary completion
- Aug 4, 2023 (Actual)
- Completion
- Aug 5, 2024 (Actual)
- Last update posted
- Aug 7, 2025
2020 – 2024
United States locations
- U.S. sites
- 37
- U.S. states
- 21
- U.S. cities
- 30
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | — |
| Alta Bates Summit | Berkeley | California | 94705 | — |
| Children's Hospital Orange County | Orange | California | 92868 | — |
| University of Colorado | Aurora | Colorado | 80045 | — |
| University of Florida Health | Jacksonville | Florida | 32209 | — |
| Wolfson Children's Hospital | Jacksonville | Florida | 32209 | — |
| South Miami Hospital | Miami | Florida | 33146 | — |
| Advent Health | Orlando | Florida | 32803 | — |
| Winnie Palmer Hospital | Orlando | Florida | 32806 | — |
| Northside Hospital Atlanta | Atlanta | Georgia | 30042 | — |
| University of Illinois | Chicago | Illinois | 60612 | — |
| Hospital of South Bend | South Bend | Indiana | 46601 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Barbara Bush Medical Center | Portland | Maine | 04102 | — |
| University of Maryland | Baltimore | Maryland | 21201 | — |
| Holy Cross Hospital | Silver Spring | Maryland | 20910 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Children's and Women's (C & W) Mott Hospital | Ann Arbor | Michigan | 48109 | — |
| Children's Health Care d/b/a Children's Minnesota | Minneapolis | Minnesota | 55404 | — |
| University of Minnesota Masonic Children's Hospital | Minneapolis | Minnesota | 55454 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| University of Mississippi | Jackson | Mississippi | 39216 | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Maimonides Hospital | Brooklyn | New York | 11219 | — |
| Mount Sinai Kravis Children's Hospital | New York | New York | 10029 | — |
| Columbia University Medical Center/New York Presbyterian Hospital | New York | New York | 10032 | — |
| NY Presbyterian Morgan Stanley Children's Hospital-Columbia | New York | New York | 10032 | — |
| West Chester Medical Center-Maria Fareri Children's Hospital | Valhalla | New York | 10595 | — |
| Levine Children's Hospital | Charlotte | North Carolina | 28203 | — |
| Grant Hospital | Columbus | Ohio | 43205 | — |
| Texas Health-Methodist Harris | Fort Worth | Texas | 76104 | — |
| Women's Hospital of Texas | Houston | Texas | 77054 | — |
| Children's Hospital of San Antonio (CHofSA) | San Antonio | Texas | 78207 | — |
| Methodist Children's Hospital | San Antonio | Texas | 78229 | — |
| North Central Baptist Hospital | San Antonio | Texas | 78258 | — |
| University of Virginia | Charlottesville | Virginia | 22947 | — |
| University of Washington | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03969992, 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 7, 2025 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03969992 live on ClinicalTrials.gov.