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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 48
SponsorKarolinska Institutet

About this trial

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 weeks of pregnancy and weighing at least 750 grams, at Phu San Hanoi Hospital in Vietnam. If SALSA is found to be safe and effective, it may offer a gentler, less invasive, and easier-to-perform option for treating respiratory distress syndrome in premature babies.

Eligibility criteria

Qualifiers

Inborn neonate (=born in the hospital), AND

Gestational age <34+0 weeks, AND

Birth weight ≥750g, AND

Age <48 hours, AND

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

440 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Karolinska Institutet

Lead sponsor

Göteborg University

Collaborator

University of Padova

Collaborator

Hanoi Obstetrics and Gynecology Hospital

Collaborator