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
Sponsors and collaborators
Karolinska Institutet
Lead sponsor
Göteborg University
Collaborator
University of Padova
Collaborator
Hanoi Obstetrics and Gynecology Hospital
Collaborator