Clinical Trial

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

Study acronym: SPLASH
Enrolling by Invitation
View on ClinicalTrials.gov →
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-09-09; most recent amendment 2026-07-09.
Status change: Not Yet Recruiting → Enrolling by Invitation 2026-05-15
Trial Details
NCT Number NCT07176117
Lead Sponsor Sharp HealthCare
Collaborators: Chiesi USA, Inc.
Conditions Respiratory Distress Syndrome (Neonatal), Surfactant
Enrollment 422 participants
Start Date 2025-11-20
Primary Completion 2030-12-31 (estimated)
Study Completion 2031-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-13