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

ID#: NCT03969992

Age: 26 - 31 weeks

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: March 04, 2020

End Date: December 30, 2021

Contact Information:
Judy Doto, RN, BSN
Jeanette Asselin, MS
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.

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