Study of Surfactant Delivery for Respiratory Distress Syndrome in Preterm Infants

This study is looking at a new way to give medicine called surfactant to premature babies (born between 28 and 35 weeks) who have Respiratory Distress Syndrome (RDS). RDS makes it hard for babies to breathe. The study will compare two types of surfactant, Infasurf and Curosurf, given using a special method called MIST while the baby is on CPAP (a breathing support machine). We want to see if giving surfactant this way is as effective as other methods in reducing the number of babies who need a breathing tube (endotracheal intubation) within 7 days. Babies can join if they are less than 48 hours old, have RDS confirmed by X-ray, are on CPAP, and need at least 30% oxygen. Babies with birth defects or other causes for breathing problems cannot participate. The study is currently recruiting 262 infants.

Study design
This is a multi-center, randomized, controlled trial. It plans to enroll 262 preterm infants.
What's involved
If your baby participates, they will receive either Infasurf or Curosurf via MIST. A second dose may be given if needed. Management will mostly be at the discretion of the clinical team.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 7 days after treatment.

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NCT06074380

Non Inferiority Trial Investigating Surfactants Administered Via MIST

Recruiting
PHASE4Up to 48InterventionalTreatment
Endeavor Health
~262 participants
Updated 2025-08-07 on ClinicalTrials.gov
What's tested:MIST surfactant

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of infants requiring Endotracheal Intubation
Measured over 7 days
Respiratory Distress Syndrome

NCT06074380

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Northshore University Healthsystem

    Evanston, Illinoisstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

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Eligibility criteria

Inclusion

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

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.
  • Number of infants requiring Endotracheal Intubation7 days

    Infants will have an endotracheal placed if their inspired oxygen is \>45% for more than 15 minutes