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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 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.

Clinical Trial 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) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03969992
Study type Interventional
Source Aerogen Pharma Limited
Contact
Status Active, not recruiting
Phase Phase 2
Start date March 4, 2020
Completion date August 31, 2024
View Details
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