By InvitationNot Applicable

Surfactant Using a Supraglottic Airway Device in Late Preterm to Early Term Infants

United States422 participantsStarted 2025-11-20

Plain-language summary

The purpose of this research is to learn new information that may help other infants that have respiratory distress syndrome and need breathing support after birth. The goal of this research is to see if continuous positive airway pressure (CPAP) alone or CPAP with surfactant administration through a less invasive method via an Airway Device (supraglottic airway device) temporarily placed above the vocal cords is better for treating respiratory distress syndrome in late preterm and early term infants.

Who can participate

Age range

33 Weeks – 38 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Newborns 33-38+6 weeks gestation at birth * ≤ 6 hours old * Respiratory Distress: \[Silverman Andersen Score (SAS) ≥ 5, or Respiratory Severity Score (RSS) ≥ 1.25\] * Clinical decision for non-invasive respiratory support * Written parental consent Exclusion Criteria: * Surrogate deliveries * Major congenital or chromosomal anomalies * Prior intubation or receipt of surfactant * Known or suspected hypoxic ischemic encephalopathy (HIE) * Known or suspected neuromuscular disorder * Unanticipated survival

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Difference in Ranked Composite of Morbidities

Timeframe: From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.

Trial details

NCT IDNCT07176117

SponsorSharp HealthCare

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-12-31

View on ClinicalTrials.gov More Respiratory Distress Syndrome (Neonatal) trials