Study for Premature Babies with Respiratory Distress Syndrome

This study is looking at whether giving a medicine called Poractant Alfa (Curosurf) to very premature babies right after birth can help prevent breathing problems. This medicine is given using a special, minimally invasive (less invasive) method. The study wants to see if giving Poractant Alfa early works better than giving it later if the baby starts to have breathing difficulties. We are looking for 200 premature babies, born before 30 weeks of pregnancy, whose parents have given consent before birth. The main goal is to see how many babies need a breathing tube (endotracheal intubation) within the first 7 days. Babies with birth defects or other reasons for breathing problems cannot join.

Study design
This is a multicenter, randomized study, meaning babies will be assigned by chance to receive Poractant Alfa either right away or later if needed. The study plans to include 200 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main outcome of the study is measured at 7 days after birth.

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NCT06007547

Prophylactic Minimally Invasive Surfactant Evaluation

Recruiting
PHASE4Up to 15InterventionalTreatment
Endeavor Health
~200 participants
Updated 2025-08-07 on ClinicalTrials.gov
What's tested:Poractant Alfa

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Endotracheal Intubation
Measured over 7 days
Respiratory Distress Syndrome, Newborn
Premature Birth
1 sites across 1 states
Illinois1
  • Matthew Derrick, MBBS · PRINCIPAL_INVESTIGATOR · Northshore Univ Healthsystem

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Eligibility criteria

Inclusion

Gestational age \<30 weeks
Antenatal consent from Parent

Exclusion

Congenital anomalies
Alternate cause of respiratory distress
  • Endotracheal Intubation7 days

    Oxygen requirement \> 45% requiring endotracheal intubation