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