Surfactant Therapy Via Supraglottic Airway to Preterm Neonates With RDS in Vietnam (NCT07098910) | Clinical Trial Compass
RecruitingNot Applicable
Surfactant Therapy Via Supraglottic Airway to Preterm Neonates With RDS in Vietnam
Vietnam440 participantsStarted 2025-09-28
Plain-language summary
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.
Who can participate
Age range
48 Hours
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Failure of surfactant therapy to prevent invasive mechanical ventilation
Timeframe: Within 72 hours after first surfactant administration