Ignite Creation Date:
2024-05-06 @ 1:14 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03969992
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2019-04-05
Brief Title:
A Dose-Ranging Study to Determine the Efficacy Safety and Tolerability of AeroFact
Sponsor:
Aerogen Pharma Limited
Organization:
Aerogen Pharma Limited
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 intubationcannulation 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
Part II Primary Objective To evaluate pulmonary outcomes and respiratory utilization at 3 6 9 and 12 months post-menstrual age PMA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None