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

Phase 2

Completed

Brief 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.

Detailed 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 & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
nCPAP alone	nCPAP	Standard of Care (nasal continuous positive airway pressure-nCPAP) with instilled bolus surfactant when medically necessary
Drug: High Dose AeroFact	AeroFact	AeroFact-high dose SF-RI 1
Drug: Low Dose AeroFact	AeroFact	AeroFact-low dose SF-RI 1

Primary Outcome Measures

Name	Time	Method
Intubation/Cannulation and Instilled Surfactant	First 7 days of life	Number of patients who require intubation/cannulation with bolus surfactant instillation

Secondary Outcome Measures

Name	Time	Method
Time to First Intubation/Cannulation and Bolus Surfactant Instillation	First 7 days of life	Time from randomization to intubation/cannulation and bolus surfactant instillation in the first 7 days of life
Proportion of Infants Who Received Multiple Doses of Bolus Surfactant	First 7 days of life
Number of Days on Invasive Mechanical Ventilation	Assessed daily from birth to 40 weeks post-menstrual age or discharge	Total number of days each participant required support with invasive mechanical ventilation
Proportion of Patients Survived Without Bronchopulmonary Dysplasia (BPD) at 36 Weeks Post-menstrual Age (PMA)	Birth to 36 weeks post-menstrual age	Total number of patients per treatment group who were alive and did not experience BPD at 36 weeks PMA
Proportion of Patients Survived Without Bronchopulmonary Dysplasia (BPD) at 40 Weeks Post-menstrual Age (PMA)	Birth to 40 weeks post-menstrual age	Total number of patients per treatment group who were alive and did not experience BPD at 40 weeks PMA

Locations (41): 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
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University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States