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

University of Texas Southwestern Medical Center40 enrolled

Overview

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 above the vocal cords ("Surfactant Administration through Laryngeal or Supraglottic Airway", called the SALSA method). The goal is to see which method is safer and more effective for preterm infants who are born at 29-36 weeks of pregnancy and have trouble breathing. What is the main question (hypothesis)? Infants who receive surfactant using the SALSA method will have fewer heart rate and breathing-related problems 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?

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Surfactant Respiratory Distress Syndrome (Neonatal)

Eligibility

Sex: ALLMin age: 0 HoursMax age: 72 Hours

Medical Language ↔ Plain English

Inclusion Criteria: * All preterm infants born between 29-36 weeks' gestation. * Infants with birthweight greater than or equal to 750 grams and admitted to the NICU on CPAP for respiratory support requiring at least FiO2 25% 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

Outcomes

Primary Outcomes

Combined bradycardia (heart rate < 100 for > 10 seconds) and hypoxemia (SpO2 < 80% for > 30 seconds) during surfactant administration

* 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

Time frame: Time of laryngoscope or supraglottic airway device insertion to removal of device

Secondary Outcomes

Procedural success rate on first attempt

* Procedure attempt is defined at the introduction of laryngoscope blade into mouth for LISA, supraglottic airway for SALSA. * Procedural success is defined by the ability to insert catheter or laryngeal mask airway and administer surfactant with less than 25% of surfactant aspirated from the stomach post administration * Rate will be calculated as a percentage of participants in each arm

Time frame: At time of surfactant administration procedure

Intubation rate

* 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

Time frame: From time of procedure to 72 hours of life

Mean number of attempts required

Procedure attempt will be defined as introduction of laryngoscope blade into mouth for LISA and introduction of supraglottic airway into mouth for SALSA.

Time frame: At time of surfactant administration

Total duration of CPAP and mechanical ventilation days

Total numbers of days on continuous end positive expiratory pressure (CPAP) and invasive mechanical ventilation

Time frame: Up to 52 weeks