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

Not Applicable

Not yet recruiting

• Conditions: Respiratory Distress Syndrome (RDS); Surfactant

• Registration Number: NCT07030270
• Lead Sponsor: University of Texas Southwestern Medical Center

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 ("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?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-29
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-17
• Study First Posted: 2025-06-22
• Last Update Submitted: 2025-06-26
• Last Update Posted: 2025-07-01
• Study Start: 2025-10-01
• Primary Completion: 2027-10
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of events of bradycardia and hypoxemia during surfactant administration	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 Outcome Measures

Name	Time	Method
Procedural success rate on first attempt	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
Intubation rate	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
Mean number of attempts required	At time of surfactant administration	Procedure attempt will be defined as introduction of laryngoscope blade into mouth.
Total duration of CPAP and mechanical ventilation days	Up to 52 weeks	Total numbers of days on continuous end positive expiratory pressure (CPAP) and invasive mechanical ventilation