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NCT Number: NCT07030270

Comparing Surfactant Administration Through Supraglottic Airway and 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?

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Key information

Conditions

Respiratory Distress Syndrome (RDS) Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Surfactant

Age range

0 hour–72 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surfactant Administration through Laryngeal or Supraglottic Airway

Procedure

Surfactant Administration through Supraglottic Airway Devices

  • Air-Q3 size 0 for neonates: < 2 kilograms
  • i-gel supraglottic airway size 1 for neonates: ≥ 2 kilograms

Surfactant Administration through Thin Catheter

Procedure

Thin Catheter

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Mean number of attempts required

    Time frame: At time of surfactant administration

    Procedure attempt will be defined as introduction of laryngoscope blade into mouth.

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Melody Chiu, M.D.

CONTACT

[email protected]

214-648-3903

Venkat Kakkilaya, M.D.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Acronym: SALTI

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Jun 22, 2025
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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