Non Inferiority Trial Investigating Surfactants Administered Via MIST
Endeavor Health
Summary
RESEARCH DESIGN Multicenter, randomized, controlled trial. RECRUITMENT Entry criteria Preterm infants 28-35 6/7 weeks' gestation and less than 48 hours of age who have a clinical diagnosis of respiratory distress syndrome. Infants who are on NCPAP and FiO2 ≥0.30 will randomized to curosurf or infasurf via MIST. Exclusion criteria Infants will be excluded if there is a congenital anomaly or an alternative cause for respiratory distress. Babies who require emergent intubation will not be enrolled in the interventions. Parental Consent will be obtained prior to randomization.
Description
INTERVENTION Infants who on CPAP who reach the threshold of 30% oxygen will be randomized to calfactant (Infasurf), 3ml/kg or poractant alfa (Curosurf), 2.5ml/kg, administered under direct laryngoscopy using a surfactant instillation catheter (MIST) 16G Angiocath (Becton Dickinson, Sandy, UT, USA). A second dose of calfactant (Infasurf) 3ml/kg or poractant alfa (Curosurf), 1.25ml/kg, will be administered via MIST their fiO2 reaches the threshold of 30% between 6 and 48 hours after the first dose. No further surfactant should be given in the first 7 days unless the infant reaches the intubati…
Eligibility
- Age range
- Up to 48 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Preterm infants 28-35 6/7 weeks' gestation and less than 48 hours of age who have a clinical diagnosis of respiratory distress syndrome confirmed by a chest x-ray on nasal continuous positive airway pressure (NCPAP) and FiO2 ≥0.30 Exclusion Criteria: * Infants will be excluded if there is a congenital anomaly or an alternative cause for respiratory distress. * Infants who require emergent intubation will not be enrolled in the interventions.
Interventions
- DrugMIST surfactant
Surfactant will be given via MIST while neonate is on CPAP
Location
- Northshore University HealthsystemEvanston, Illinois