Home › Respiratory Distress Syndrome › NCT06074380

Non Inferiority Trial Investigating Surfactants Administered Via MIST

Who can join

48 Hours · All sexes

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.

About the study

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.

What is being tested

• MIST surfactant (drug)

Sponsor: Endeavor Health · Participants: 262 · Started: Jan 1, 2024

Contact the study team

• Matthew Derrick · Phone: 18475702920

Official record on ClinicalTrials.gov — NCT06074380

Locations in the U.S.

Conditions

• Respiratory Distress Syndrome

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.