Status:
RECRUITING
Prophylactic Minimally Invasive Surfactant Evaluation
Lead Sponsor:
Endeavor Health
Collaborating Sponsors:
Chiesi USA, Inc.
Conditions:
Respiratory Distress Syndrome, Newborn
Premature Birth
Eligibility:
All Genders
Up to 15 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to explore the question: Does prophylactic administration of exogenous surfactant in the delivery room, using a minimally-invasive technique, improve outcome in preterm in...
Detailed Description
RESEARCH DESIGN Multicenter, randomized, controlled trial. Northshore Evanston Hospital will be the primary site. It is hoped that Northwest Community, University of Chicago, Edwards Hospital, Advoca...
Eligibility Criteria
Inclusion
- Gestational age \<30 weeks
- Antenatal consent from Parent
Exclusion
- Congenital anomalies
- Alternate cause of respiratory distress
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06007547
Start Date
January 1 2024
End Date
July 31 2027
Last Update
August 7 2025
Active Locations (1)
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1
Northshore University Healthsystem
Evanston, Illinois, United States, 60201