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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: University of Texas Southwestern Medical Center • ClinicalTrials.gov ID: NCT07030270

Registry updated: 2026-09-16
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Description

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?

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

Eligibility criteria

Inclusion Criteria: * All preterm infants born between 29-36 weeks' gestation. * Infants with birthweight greater than or equal to 750 grams and admitted to the NICU on CPAP for respiratory support requiring at least FiO2 25% and qualify for LISA procedure Exclusion Criteria: * Infants who require intubation prior to surfactant therapy * Infants with known severe congenital anomalies (complex congenital heart disease, airway and central nervous system anomalies) * Infants whose birth weight is less than 750 grams or oropharynx unable to accommodate laryngeal mask airways

Conditions

Surfactant Respiratory Distress Syndrome (Neonatal)

Locations

  • Parkland Health and Hospital Systems — Dallas, Texas, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record