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

• Status: Recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aerogen Pharma Limited

Criteria

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