Surfactant given through a laryngeal mask for preterm babies with RDS in Vietnam
Surfactant Therapy Via Supraglottic Airway Device Versus Endotracheal Intubation to Prevent Mechanical Ventilation in Preterm Neonates With Respiratory Distress Syndrome: An Open-label, Non-inferiority, Randomized Controlled Trial at a Level-III Neonatal Intensive Care Unit in Vietnam
For preterm babies under 34 weeks with respiratory distress, the team will try giving surfactant through a soft throat mask (SALSA) instead of an endotracheal tube (INSURE) to see if it reduces the need for invasive breathing support.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 440 (estimated) |
| Ages | N/A to 48 Hours |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Hanoi) |
| Trial ID | NCT07098910 on ClinicalTrials.gov |
What this trial studies
This randomized trial will compare surfactant delivery via a supraglottic/laryngeal mask airway (SALSA) to the standard INSURE technique (intubation, surfactant, extubation) in preterm infants with respiratory distress syndrome. Eligible inborn neonates are under 34+0 weeks gestation, weigh at least 750 g, are less than 48 hours old, and require surfactant while on non-invasive support with FiO2 >0.30. The primary outcome is avoidance of invasive mechanical ventilation within three days of treatment, with safety and feasibility outcomes also recorded. The trial is being conducted at Phu San Hanoi Hospital with international academic collaborators and uses preterm-sized supraglottic devices introduced after a prior feasibility study.
Who should consider this trial
Good fit: Inborn preterm infants born before 34 weeks, weighing ≥750 g, under 48 hours old with RDS on CPAP/NIPPV and requiring FiO2 >0.30 to maintain target oxygenation are the intended participants.
Not a fit: Infants already intubated or mechanically ventilated, those with prior surfactant, known pneumothorax, major malformations, or who need immediate invasive support are unlikely to benefit from SALSA in this protocol.
Why it matters
Potential benefit: If successful, SALSA could reduce the need for endotracheal intubation and its complications, making surfactant delivery safer and simpler for very preterm infants, especially in resource-limited settings.
How similar studies have performed: Smaller studies and a recent feasibility study using preterm-sized supraglottic devices have shown promising results for SALSA, but large randomized data in very preterm populations remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hanoi
- Phu San Hanoi Hospital - Hanoi Obstetrics and Gynecology Hospital — Hanoi, Vietnam (Recruiting)
Study contacts
- Principal investigator: Tobias Alfvén, Professor, M.D, Ph.D — Department of Global Public Health, Karolinska Institutet, Solna, Sweden
- Study coordinator: Tobias Alfvén, Professor, M.D, Ph.D
- Email: tobias.alfven@ki.se
- Phone: +46 70 757 80 93
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.