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

Part of paid clinical trials in Chula Vista, California.

Sponsor
Sharp HealthCare
Study ID
NCT07176117
Status
Enrolling By Invitation

Conditions

  • Respiratory Distress Syndrome (Neonatal)
  • Surfactant

Eligibility Criteria

Sex
ALL
Age
33 Weeks - 38 Weeks
Healthy Volunteers
Not accepted

Interventions

  • Surfactant Administration Through Laryngeal or Supraglottic Airway (SALSA) — PROCEDURE
    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.
  • Continuous Positive Airway Pressure (CPAP) — PROCEDURE
    Infants to receive continuation of non-invasive respiratory support will remain on continuous positive airway pressure (CPAP).

Study Details

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.

Key Dates

Start date
Nov 20, 2025
Status verified
May 2026
Primary completion
Dec 31, 2030
Completion
Jun 30, 2031

Study Design

Enrollment
422 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Prophylactic Surfactant
    A single dose of surfactant (Curosurf) will be given via Surfactant Administration Through Laryngeal or Supraglottic Airways (SALSA). Infants who receive SALSA will remain on non-invasive respiratory support (Continuous Positive Airway Pressure).
  • Active Comparator: Expectant Management (CPAP)
    For participating infants randomly assigned to receive continuation of non-invasive respiratory support, they will remain on continuous positive airway pressure (CPAP).

Primary Outcome Measure

Difference in Ranked Composite of Morbidities [ Time Frame: From date of birth (day of life 1) through study completion at birth-hospital discharge, up to 6 months of age. ]

Locations (3)

FacilityCityStateZIPSite coordinators
Sharp Chula Vista Medical CenterChula VistaCalifornia91911-
Sharp Grossmont HospitalLa MesaCalifornia91942-
Sharp Mary Birch Hospital for Women & NewbornsSan DiegoCalifornia92123-

Find similar trials in Chula Vista, CA

By research site
Sharp Chula Vista Medical Center· Chula Vista, CASharp Grossmont Hospital· La Mesa, CASharp Mary Birch Hospital for Women & Newborns· San Diego, CA

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