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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-06-01

Study Completion Date

2029-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Respiratory Distress Syndrome (RDS) Surfactant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Surfactant Administration through Laryngeal or Supraglottic Airway

Group Type EXPERIMENTAL

Surfactant Administration through Laryngeal or Supraglottic Airway

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Surfactant Administration through Thin Catheter

Intervention Type PROCEDURE

Thin Catheter

Interventions

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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

Intervention Type PROCEDURE

Surfactant Administration through Thin Catheter

Thin Catheter

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

0 Hours

Maximum Eligible Age

72 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No