MedTrace Logo

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

NCT07176117 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 422

Last updated 2026-05-19

No results posted yet for this study

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.

Conditions

  • Respiratory Distress Syndrome (Neonatal)
  • Surfactant

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).

Sponsors & Collaborators

  • Chiesi USA, Inc.

    collaborator INDUSTRY

  • Sharp HealthCare

    lead OTHER

Principal Investigators

  • Anup Katheria, MD · Sharp HealthCare

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
33 Weeks
Max Age
38 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-20
Primary Completion
2030-12-31
Completion
2031-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07176117 on ClinicalTrials.gov