Non Inferiority Trial Investigating Surfactants Administered Via MIST
ConditionRespiratory Distress Syndrome
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeUp to 48
SponsorEndeavor Health
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- MIST surfactant
Treatment groups
262 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov