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Surfactant Therapy Via Supraglottic Airway to Preterm Neonates With RDS in Vietnam

RecruitingNAAges any - 48 HoursAllKarolinska Institutet
NCT07098910 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Preterm babies often have trouble breathing because their lungs are not fully developed. This condition is called respiratory distress syndrome (RDS). A medicine called surfactant helps their lungs open up and work better. It is usually given through a procedure called INSURE, where a breathing tube is placed into the baby's trachea (via an endotracheal tube) to deliver the medicine. While effective, this method is invasive and can be uncomfortable and risky for the baby. A newer, less invasive method called SALSA uses a soft mask placed in the throat (a laryngeal mask airway) instead of an endotracheal tube to give the surfactant. This randomized controlled trial will compare SALSA to the traditional INSURE method to see if it works just as well in preventing the need for invasive breathing support within three days of treatment. The study will include preterm babies born before 34 we

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📋 Eligibility rules (as published)
Inclusion Criteria: * Inborn neonate (=born in the hospital), AND * Gestational age \<34+0 weeks, AND * Birth weight ≥750g, AND * Age \<48 hours, AND * Diagnosis of RDS, confirmed with a chest x-ray or lung ultrasound, except in cases where immediate treatment is necessary and imaging would cause a delay AND * Indication for surfactant treatment: Infant on non-invasive support (CPAP/NIPPV) and FiO2 \>0.30 to maintain oxygen saturation (SpO2) between 90% and 95% Exclusion Criteria: * Severe respiratory insufficiency in need of intubation at delivery room * Severe respiratory insufficiency in need of intubation and invasive mechanical ventilation after arrival to NICU * Previous surfactant administration * Previous invasive mechanical ventilation * Known pneumothorax * Major malformations * Physician not confident with study intervention * The physician decided not to include the patient due to a preference for performing INSURE * Excluded due to time constraints preventing completion of informed consent and trial procedures
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What it tests

  • Surfactant Administration Through Laryngeal or Supraglottic Airways (SALSA)
  • Intubation - Surfactant administration - Extubation (INSURE)
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Where

1 site
Phu San Hanoi Hospital - Hanoi Obstetrics and Gynecology Hospital
Hanoi, Vietnam
🤝 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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