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NOT YET RECRUITING
NCT07176117
NA

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

Sponsor: Sharp HealthCare

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.

Official title: Surfactant Prophylaxis in LAte Preterm to Early Term Infants Using a Supraglottic Airway Device to Help Improve Outcomes

Key Details

Gender

All

Age Range

33 Weeks - 38 Weeks

Study Type

INTERVENTIONAL

Enrollment

422

Start Date

2025-10-01

Completion Date

2031-06-30

Last Updated

2025-09-16

Healthy Volunteers

No

Interventions

PROCEDURE

Surfactant Administration Through Laryngeal or Supraglottic Airway (SALSA)

A single dose of surfactant will be given via Surfactant Administration Through Laryngeal or Supraglottic Airways (SALSA). A supraglottic airway device will be used as a standardized procedure for surfactant administration via SALSA using an AirLife Air-Q.

PROCEDURE

Continuous Positive Airway Pressure (CPAP)

Infants to receive continuation of non-invasive respiratory support will remain on continuous positive airway pressure (CPAP).

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