Actively Recruiting
Surfactant Therapy Via Supraglottic Airway to Preterm Neonates With RDS in Vietnam
Led by Karolinska Institutet · Updated on 2025-09-22
440
Participants Needed
1
Research Sites
183 weeks
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
G
Göteborg University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Surfactant Therapy Via Supraglottic Airway to Preterm Neonates With RDS in Vietnam
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Baby is born in the hospital
- Gestational age less than 34 weeks
- Birth weight at least 750 grams
- Age less than 48 hours
- Diagnosed with respiratory distress syndrome confirmed by chest x-ray or lung ultrasound unless immediate treatment is needed
- Requires surfactant treatment while on non-invasive support with oxygen needs above 30% to maintain oxygen saturation between 90% and 95%
You will not qualify if you...
- Severe breathing problems needing intubation in the delivery room
- Severe breathing problems needing intubation and invasive mechanical ventilation after arriving at NICU
- Previous surfactant therapy
- Previous invasive mechanical ventilation
- Known pneumothorax
- Major malformations
- Physician not confident with study procedure
- Physician prefers to perform INSURE instead
- Unable to complete informed consent and trial procedures due to time constraints
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Phu San Hanoi Hospital - Hanoi Obstetrics and Gynecology Hospital
Hanoi, Vietnam, 118000
Actively Recruiting
Research Team
T
Tobias Alfvén, Professor, M.D, Ph.D
CONTACT
M
Mårten Larsson, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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