Condition: Respiratory Distress Syndrome in Premature Infant · Sponsor: Karolinska Institutet
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.
This description comes directly from the study's public registry record.
Tobias Alfvén, Professor, M.D, Ph.D · +46 70 757 80 93 · tobias.alfven@ki.se
Mårten Larsson, M.D · +46 704 24 09 72 · marten.larsson.2@gu.se
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| Phu San Hanoi Hospital - Hanoi Obstetrics and Gynecology Hospital | Hanoi, Vietnam | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07098910