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

RecruitingNAAges 0 Hours - 72 HoursAllUniversity of Texas Southwestern Medical Center
NCT07030270 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 th

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📋 Eligibility rules (as published)
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
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What it tests

  • Surfactant Administration through Laryngeal or Supraglottic Airway
  • Surfactant Administration through Thin Catheter
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Where

1 site
Parkland Health and Hospital Systems
Dallas, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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