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

Respiratory Distress Syndrome in Premature Infant Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03969992
• Other study ID #: APC-AF-CLN-002
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 4, 2020
• Est. completion date: August 31, 2024

Study information

• Verified date: January 2024
• Source: Aerogen Pharma Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Part I Primary Objective To determine an optimal dose of AeroFact administered by nasal continuous positive airway pressure (nCPAP) versus stand of care in reducing the rate of intubation/cannulation and bolus surfactant instillation in the first 7 days after birth.

Part II Primary Objective To evaluate pulmonary outcomes and respiratory utilization at 3, 6, 9, and 12 months post-menstrual age (PMA)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 261
• Est. completion date: August 31, 2024
• Est. primary completion date: August 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 26 Weeks to 31 Weeks

Eligibility

Inclusion Criteria:

1. Parental consent obtained prior to study procedures being performed (pre-natal consent is allowed)

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:

1. Apgar score less than or equal to 5 at five minutes after birth

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

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome in Premature Infant
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Drug:
• AeroFact
Aerosolized SF-RI 1

Other:
• nCPAP
nCPAP (nasal continuous positive airway pressure) alone

Locations

Country	Name	City	State
Canada	IWK Hospital	Halifax	Nova Scotia
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	CHU de Québec-Université Laval	Québec City	Quebec
Canada	Mt. Sinai Hospital	Toronto	Ontario
United States	Northside Hospital Atlanta	Atlanta	Georgia
United States	University of Colorado	Aurora	Colorado
United States	University of Maryland	Baltimore	Maryland
United States	Alta Bates Summit	Berkeley	California
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Maimonides Hospital	Brooklyn	New York
United States	Levine Children's Hospital	Charlotte	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	University of Illinois	Chicago	Illinois
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	University of Mississippi	Jackson	Mississippi
United States	University of Florida Health	Jacksonville	Florida
United States	Wolfson Children's Hospital	Jacksonville	Florida
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	University of Kentucky	Louisville	Kentucky
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	Mount Sinai Kravis Children's Hospital	New York	New York
United States	NY Presbyterian Morgan Stanley Children's Hospital-Columbia	New York	New York
United States	Advent Health	Orlando	Florida
United States	Mayo Clinic	Rochester	Minnesota
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 Washington	Seattle	Washington
United States	Holy Cross Hospital	Silver Spring	Maryland
United States	Hospital of South Bend	South Bend	Indiana
United States	West Chester Medical Center-Maria Fareri Children's Hospital	Valhalla	New York

Sponsors (1)

Lead Sponsor	Collaborator
Aerogen Pharma Limited

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of intubation/cannulation and instilled surfactant	Number of patients who require intubation/cannulation with bolus surfactant instillation	7 days
Primary	Percent of patients with respiratory symptoms requiring intervention across groups	Comparison of respiratory symptoms (Asthma/URI) and respiratory medications between groups	12 months
Primary	Percent of patients requiring supplemental oxygen and visits for medical care (Doctor's office/ER/Hospitalization)	Assess need for supplemental oxygen and other respiratory support and visits to physician office/ER/hospitalizations between groups	12 months
Secondary	Percent of patients requiring repeat surfactant dosing between groups	Assess the need for more than one dose of surfactant between groups	7 days