NCT07030270

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 0 Hours – 72 Hours
• Healthy volunteers: Not accepted

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?

Conditions

• Respiratory Distress Syndrome (RDS)
• Surfactant

Interventions

Type	Name	Description
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
PROCEDURE	Surfactant Administration through Thin Catheter	Thin Catheter

Timeline

• Start date: 2026-06-01
• Primary completion: 2028-06-01
• Completion: 2029-06-01
• First posted: 2025-06-22
• Last updated: 2026-02-04