MedTrace Logo

Non Inferiority Trial Investigating Surfactants Administered Via MIST

NCT06074380 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 262

Last updated 2025-08-07

No results posted yet for this study

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.

Conditions

  • Respiratory Distress Syndrome

Interventions

DRUG

MIST surfactant

Surfactant will be given via MIST while neonate is on CPAP

Sponsors & Collaborators

  • Endeavor Health

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
48 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2025-12-30
Completion
2027-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06074380 on ClinicalTrials.gov