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

Not Applicable

Not yet recruiting

• Conditions: Respiratory Distress Syndrome (Neonatal); Surfactant

• Registration Number: NCT07176117
• Lead Sponsor: Sharp HealthCare

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-08-27
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-09
• Last Update Submitted: 2025-09-09
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16
• Study Start: 2025-10-01
• Primary Completion: 2030-12-31
• Study Completion: 2031-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 422

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Difference in Ranked Composite of Morbidities	From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.	Determine if there is a difference in ranked composite of morbidities including death, development of pneumothorax/ pulmonary air leaks, Respiratory Severity Score (RSS), time to initial feeding, and LOS (length of hospital stay) between the treatment and control groups using a linked count of participants who fall within each prespecified rank.

Secondary Outcome Measures

Name	Time	Method
Length of Hospital Stay	From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age.	Length of hospital stay (LOS), days.

Trial Locations

Locations (3)

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