NCT07098910 Surfactant Therapy Via Supraglottic Airway to Preterm Neonates With RDS in Vietnam
| NCT ID | NCT07098910 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Respiratory Distress Syndrome in Premature Infant |
| Study Type | INTERVENTIONAL |
| Enrollment | 440 participants |
| Start Date | 2025-09-28 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 440 participants in total. It began in 2025-09-28 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Tobias Alfvén, Professor, M.D, Ph.D
PRINCIPAL INVESTIGATOR
Department of Global Public Health, Karolinska Institutet, Solna, Sweden
Frequently Asked Questions
Who can join the NCT07098910 clinical trial?
This trial is open to participants of all sexes, up to 48 Hours, studying Respiratory Distress Syndrome in Premature Infant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07098910 currently recruiting?
Yes, NCT07098910 is actively recruiting participants. Contact the research team at tobias.alfven@ki.se for enrollment information.
Where is the NCT07098910 trial being conducted?
This trial is being conducted at Hanoi, Vietnam.
Who is sponsoring the NCT07098910 clinical trial?
NCT07098910 is sponsored by Karolinska Institutet. The principal investigator is Tobias Alfvén, Professor, M.D, Ph.D at Department of Global Public Health, Karolinska Institutet, Solna, Sweden. The trial plans to enroll 440 participants.