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

Launched by KAROLINSKA INSTITUTET · Jul 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help premature babies who have trouble breathing due to a condition called respiratory distress syndrome (RDS). Normally, a medicine called surfactant is given through a tube placed into the baby’s windpipe to help their lungs work better. While this method works well, it can be uncomfortable and may have some risks. The trial is testing a gentler way to give surfactant using a soft mask placed in the baby’s throat instead of a tube. Researchers want to see if this new method is just as safe and effective in helping babies breathe better without needing more intense breathing support.

The study is for babies born before 34 weeks of pregnancy who weigh at least 750 grams and who develop breathing problems soon after birth. These babies must be less than 2 days old and need surfactant treatment but are not yet on a breathing machine. If a baby’s breathing is very severe or if they have other serious health issues, they would not be eligible. Families of babies who join the study can expect their baby to receive surfactant either by the usual tube method or the newer mask method, and doctors will closely monitor how well the baby does. If the new method proves safe and helpful, it could offer a softer, easier way to treat breathing problems in premature babies.

Gender

ALL

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