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

February 2, 2026 updated by: Melody Chiu, University of Texas Southwestern Medical Center

A Clinical Trial Comparing Surfactant Administration Through Supraglottic Airway or Thin Catheter for Preterm Infants

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 ("Surfactant Administration through Laryngeal or Supraglottic Airway", called the SALSA method). The goal is to see which method is safer and more effective for 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 breathing-related problems and fewer short-term complications 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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surfactant Administration through Laryngeal or Supraglottic Airway
Procedure: Surfactant Administration through Laryngeal or Supraglottic Airway

Surfactant Administration through Supraglottic Airway Devices

  • Air-Q3 size 0 for neonates: < 2 kilograms
  • i-gel supraglottic airway size 1 for neonates: ≥ 2 kilograms
Active Comparator: Surfactant Administration through Thin Catheter
Procedure: Surfactant Administration through Thin Catheter
Thin Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of events of bradycardia and hypoxemia during surfactant administration
Time Frame: Time of surfactant administration to completion of procedure
  • Bradycardia: defined as heart rate < 100 beats per minute for > 10 seconds. Heart rate will be obtained from participant's heart rate monitor.
  • Hypoxemia: oxygen saturation (SpO2) =< 80% for > 30 seconds. Oxygen saturation will be obtained from participant's pulse oximeter monitor
  • Events will be recorded by bedside respiratory therapy and/or bedside nurse during the procedure
Time of surfactant administration to completion of procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural success rate on first attempt
Time Frame: At time of surfactant administration procedure
  • Procedure attempt is defined at the introduction of laryngoscope blade into mouth.
  • Procedural success is defined by the ability to insert catheter or laryngeal mask airway and administer surfactant without surfactant aspirated from the stomach post administration
  • Rate will be calculated as a percentage of participants in each arm
At time of surfactant administration procedure
Intubation rate
Time Frame: From time of procedure to 72 hours of life
  • Rate will be calculated as a percentage of participants in each arm Invasive mechanical ventilation within first 72 hours of life after surfactant
  • Participants' need for and timing of intubation will be obtained from electronic medical record
From time of procedure to 72 hours of life
Mean number of attempts required
Time Frame: At time of surfactant administration
Procedure attempt will be defined as introduction of laryngoscope blade into mouth.
At time of surfactant administration
Total duration of CPAP and mechanical ventilation days
Time Frame: Up to 52 weeks
Total numbers of days on continuous end positive expiratory pressure (CPAP) and invasive mechanical ventilation
Up to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Melody Chiu, M.D., University of Texas Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

May 29, 2025

First Submitted That Met QC Criteria

June 17, 2025

First Posted (Actual)

June 22, 2025

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU20250018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be collected and de-identified at the time of analysis. IPD availability does not to enhance study results.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Surfactant

Clinical Trials on Surfactant Administration through Laryngeal or Supraglottic Airway

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe