Prophylactic Minimally Invasive Surfactant Evaluation
Endeavor Health
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?
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, Advocate Park Ridge, Advocate Oak Lawn and Advocate Illinois Masonic will also join the study. RECRUITMENT Entry criteria Inborn preterm infants 22 0/7-29 6/7 weeks' gestation, with be randomized to prophylactic Minimally Invasive Surfactant Therapy (MIST) in the delivery room compared to rescue MIST if fraction of inspired oxygen (FiO2) ≥0.30 at less than 48 hours of age. Babies in both groups will be…
Eligibility
- Age range
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Gestational age \<30 weeks * Antenatal consent from Parent Exclusion Criteria: * Congenital anomalies * Alternate cause of respiratory distress
Interventions
- DrugPoractant Alfa
Poractant alfa (Curosurf) 200mg/kg administered under direct laryngoscopy using a surfactant instillation catheter
Location
- Northshore University HealthsystemEvanston, Illinois