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Enrolling By Invitation NCT07176117

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

Conditions: Respiratory Distress Syndrome (Neonatal), Surfactant

Sex: All
Ages: 33 Weeks – 38 Weeks
Healthy volunteers: No
Phase: NA
Enrollment: 422
Sponsor: Sharp HealthCare

Location: Sharp Chula Vista Medical Center Chula Vista California

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.

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07176117). StuddyBuddy aggregates publicly available trial information.