Surfactant Using a Supraglottic Airway Device in Late Preterm to Early Term Infants
Enrolling by invitation · Not applicable
Conditions studied: Respiratory Distress Syndrome (Neonatal), Surfactant
In brief
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.
Key facts
- Study ID
- NCT07176117
- Run by
- Sharp HealthCare
- People needed
- 422
- Starts
- 2025-11-20
- Expected to finish
- 2031-06-30
- Last updated by the study team
- 2026-07-13
Who can join
Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Sharp Chula Vista Medical Center — Chula Vista, California, United States
- Sharp Grossmont Hospital — La Mesa, California, United States
- Sharp Mary Birch Hospital for Women & Newborns — San Diego, California, United States
Full record on ClinicalTrials.gov
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