Surfactant given through a laryngeal mask for preterm babies with RDS in Vietnam

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Surfactant delivery methods in preterm infants with RDS in Sweden

  This study tests different ways of giving surfactant to preterm babies with respiratory distress to see which method works best when care is routine.

  Recruiting Vastra Gotaland Region · Gothenburg · NCT07550218

• Lung ultrasound score to guide surfactant timing in preterm newborns

  This study tests whether using a lung ultrasound score can speed up diagnosing severe RDS and getting surfactant to moderately and late-preterm babies in the NICU.

  Recruiting Hackensack Meridian Health · Hackensack, New Jersey · NCT07442669

• Predicting which newborns in a lower-level NICU will need extended breathing support

  This project will test whether analyzing a newborn's stomach fluid right after birth can help predict which babies born at 32+ weeks and attended by the neonatal resuscitation team will need breathing support for more than six hours.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07344714

• Optimising breathing support at extubation for very preterm infants

  This trial will try starting nasal CPAP before removing the breathing tube versus starting it after extubation to see if that reduces oxygen drops in very preterm infants.

  Recruiting at 3 sites Murdoch Childrens Research Institute · Melbourne, Victoria and 2 other locations · NCT07251790

• Giving surfactant to premature infants using a thin catheter at birth

  This study is testing if giving a special lung treatment to very premature babies right after birth using a thin tube can help them breathe better and need less breathing support in their first few days of life.

  Recruiting University College Dublin · Dublin, None Selected · NCT06557551

• Evaluating a new surfactant treatment for respiratory distress in preterm infants in Africa

  This study is testing a new way to give surfactant treatment to preterm infants with breathing problems in Africa to see if it helps them do better than the usual care.

  Recruiting at 2 sites Phase 4 Indiana University · Bangui and 7 other locations · NCT06554522

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.