An interventional study of Surfactant Administration through Laryngeal or Supraglottic Airway and Surfactant Administration through Thin Catheter in Surfactant and Respiratory Distress Syndrome (Neonatal), sponsored by University of Texas Southwestern Medical Center. Recruiting at 1 site in United States. Open to participants aged 0 Hours to 72 Hours. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Treatment
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?
377 studies on the registry are indexed under Pulmonary Atelectasis; 93 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 268 interventional studies indexed under Pulmonary Atelectasis.
Browse Pulmonary Atelectasis studies →University of Texas Southwestern Medical Center is the lead sponsor of 1,010 studies on the registry; 199 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
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The criteria were revised on the registry on Nov 6, 2026. See what changed
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Exclusion Criteria:
Procedure: Surfactant Administration through Laryngeal or Supraglottic Airway
Procedure: Surfactant Administration through Thin Catheter
Surfactant Administration through Supraglottic Airway Devices -AerVia sizes S, M, L, XL
Thin Catheter
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
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
Plan to share: No — Data will be collected and de-identified at the time of analysis. IPD availability does not to enhance study results.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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