Prophylactic Minimally Invasive Surfactant Evaluation
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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 infants 22-29 weeks' gestation compared to rescue treatment using the same technique?
Eligibility
Participation Requirements
Sex: All
Maximum Age: Newborn
Healthy Volunteers: t
View:
• Gestational age \<30 weeks
• Antenatal consent from Parent
Locations
United States
Illinois
Northshore University Healthsystem
RECRUITING
Evanston
Contact Information
Primary
Matthew Derrick, MBBS
mderrick@northshore.org
8475702920
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 200
Treatments
Experimental: Prophylactic Surfactant via Minimally Invasive Technique
Infants randomized to prophylactic surfactant treatment will receive a dose of poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter (MIST) 16G Angiocath (Becton Dickinson, Sandy, UT, USA), at a dosage of 200 mg/kg as soon as possible after delivery (within 15 minutes).
Active_comparator: Rescue Surfactant via Minimally Invasive Technique
The control group will be given surfactant will receive a dose of poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter (MIST) 16G Angiocath (Becton Dickinson, Sandy, UT, USA), at a dosage of 200 mg/kg if their fiO2 reaches a threshold of ≥30% within the first 48 hours of life.
Related Therapeutic Areas
Sponsors
Collaborators: Chiesi USA, Inc.
Leads: Endeavor Health