A Clinical Trial Comparing Surfactant Administration Through Supraglottic Airway or Thin Catheter for Preterm Infants
University of Texas Southwestern Medical Center
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?
Eligibility
- Age range
- 0–72 years
- Sex
- All
- Healthy volunteers
- No
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