Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT07030270
Status
Recruiting
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Conditions

  • Respiratory Distress Syndrome (Neonatal)
  • Surfactant

Eligibility Criteria

Sex
ALL
Age
0 Hours - 72 Hours
Healthy Volunteers
Not accepted

Interventions

  • Surfactant Administration through Laryngeal or Supraglottic Airway — PROCEDURE
    Surfactant Administration through Supraglottic Airway Devices -AerVia sizes S, M, L, XL
  • Surfactant Administration through Thin Catheter — PROCEDURE
    Thin Catheter

Study Details

What is this study about? This study is comparing two ways of giving surfactant, a medicine that helps premature infants breathe better. Surfactant can be given using a thin tube ("Less Invasive Surfactant Administration", called the LISA method) or through a small airway device placed in the baby's throat above the vocal cords ("Surfactant Administration through Laryngeal or Supraglottic Airway", called the SALSA method). The goal is to see which method is safer and more effective for preterm infants who are born at 29-36 weeks of pregnancy and have trouble breathing. What is the main question (hypothesis)? Infants who receive surfactant using the SALSA method will have fewer heart rate and breathing-related problems than those who receive it using the LISA method. What are the aims? Aim 1: Are babies in the SALSA group less likely to have low heart rate or low oxygen levels during the procedure compared to babies in the LISA group? Aim 2: Do fewer babies in the SALSA group need to be put on a breathing machine within the first 72 hours of life? Aim 3: Does the SALSA method help reduce the overall time babies need breathing support and lower the cost of their care in the NICU?

Key Dates

First listed
Jun 22, 2025
Start date
Aug 5, 2026
Status verified
Aug 2026
Primary completion
Jul 31, 2028
Completion
Jun 30, 2030

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Surfactant Administration through Laryngeal or Supraglottic Airway
  • Active Comparator: Surfactant Administration through Thin Catheter

Primary Outcome Measure

Combined bradycardia (heart rate < 100 for > 10 seconds) and hypoxemia (SpO2 < 80% for > 30 seconds) during surfactant administration [ Time Frame: Time of laryngoscope or supraglottic airway device insertion to removal of device ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Parkland Health and Hospital SystemsDallasTexas75235
Melody Chiu, MD

Find similar trials in Dallas, TX

By research site
Parkland Health and Hospital Systems· Dallas, TX

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