Non Inferiority Trial Investigating Surfactants Administered Via MIST
Endeavor Health
262 participants
Jan 1, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria1
- 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 Criteria2
- 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.
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Interventions
Surfactant will be given via MIST while neonate is on CPAP
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06074380