NCT07030270 · University of Texas Southwestern Medical Center
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
(SALTI)
What this study is about
What is this study about? This study is comparing two ways of giving surfactant, a medicine that helps premature infants breathe better.
View original scientific description
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.
Interventions
PROCEDURE
Surfactant Administration through Laryngeal or Supraglottic Airway
Surfactant Administration through Supraglottic Airway Devices -AerVia sizes S, M, L, XL
PROCEDURE
Surfactant Administration through Thin Catheter
Thin Catheter
Primary outcome measures
Number of events of bradycardia and hypoxemia during surfactant administration
Time frame: Time of surfactant administration to completion of procedure
* 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Dallas, Texas
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 27, 2026 · Source of record for eligibility and locations