Surfactants for Respiratory Distress Syndrome in Preterm Infants
Non Inferiority Trial Investigating Surfactants Administered Via MIST
Recruiting
Phase 4
Interventional Study
Respiratory Distress Syndrome
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- Up to 48 Hours
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 262 (estimated)
- Sponsor
- Endeavor Health · Other
Who this trial is looking for
This trial is looking for preterm babies aged 28-35 weeks who are having trouble breathing. If eligible, they will receive either curosurf or infasurf treatment through a special technique called MIST.
Are You a Good Fit for This Trial?
You may be able to join if
- I am a preterm infant born between 28 and 35 weeks of gestation.
- I am less than 48 hours old.
- I have been diagnosed with respiratory distress syndrome.
- I am on NCPAP.
- I require FiO2 of 0.30 or higher.
You may not be able to join if
- I have a congenital anomaly.
- I have an alternative cause for respiratory distress.
- I require emergency intubation.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
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 alt…
Trial Locations
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Eligibility Criteria
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 exclud…
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