CompletedPhase 2

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

United States261 participantsStarted 2020-03-04

Plain-language 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.

Who can participate

Age range26 Weeks – 31 Weeks

SexALL

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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

What they're measuring

Intubation/Cannulation and Instilled Surfactant

Timeframe: First 7 days of life

Trial details

NCT IDNCT03969992

SponsorAerogen Pharma Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-08-04

Results submitted2025-06-20

View on ClinicalTrials.gov More Respiratory Distress Syndrome in Premature Infant trials