Recruiting

SALSA vs. LISA

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT07030270

Conditions

Surfactant

Respiratory Distress Syndrome (Neonatal)

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Surfactant Administration through Laryngeal or Supraglottic Airway

Surfactant Administration through Thin Catheter

Study Details

Brief summary:

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 or after 29 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?

Conditions

Surfactant

Respiratory Distress Syndrome (Neonatal)

Study ID

NCT07030270

Start date

Aug 5, 2026

Status verified date

Aug, 2026

Completion date

Aug, 2030

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All preterm infants born at or greater than 29 weeks' gestational age (29-36 weeks' GA)
  • Infants with birthweight greater than or equal to 750 grams and admitted to the NICU on CPAP for respiratory support requiring 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Surfactant Administration through Laryngeal or Supraglottic Airway

active comparator: Surfactant Administration through Thin Catheter

Interventions

Surfactant Administration through Laryngeal or Supraglottic Airway

Surfactant Administration through Supraglottic Airway Devices

-AerVia sizes S, M, L, XL

Surfactant Administration through Thin Catheter

Thin Catheter

Primary outcome measure

  • Number of events of bradycardia and hypoxemia during surfactant administration [ Time Frame: Time of surfactant administration to completion of procedure ]

Central Contacts and Locations

Central contacts

Melody Chiu, M.D.

214-648-3903melody.chiu@utsouthwestern.edu

Kathryn Mazioniene, R.N.

kathryn.mazioniene@utsouthwestern.edu

Locations

Parkland Health and Hospital Systems

Recruiting

Dallas, Texas, United States, 75235

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • preterm infants
  • surfactant therapy
  • respiratory distress syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-08-27.