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

The University of Texas System (UT)

Status: Begins enrollment in 2 months

Conditions: Respiratory Distress Syndrome (RDS); Surfactant

Treatments: Procedure: Surfactant Administration through Thin Catheter; Procedure: Surfactant Administration through Laryngeal or Supraglottic Airway

Study type: Interventional

Funder types: Other

Identifiers

NCT07030270

STU-2025-0018

Details and patient eligibility

About

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?

Enrollment: 40 estimated patients

Sex: All

Ages: Under 72 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

Surfactant Administration through Laryngeal or Supraglottic Airway

Experimental group

Treatment:

Procedure: Surfactant Administration through Laryngeal or Supraglottic Airway

Surfactant Administration through Thin Catheter

Active Comparator group

Treatment:

Procedure: Surfactant Administration through Thin Catheter