Status:
COMPLETED
Feasibility Study of Placement and Surfactant Administration Through a Preterm Size Laryngeal Mask Airway in Very Low Birth Weight Neonates With Respiratory Distress Syndrome
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
Hanoi Medical University
Hanoi Obstetrics and Gynecology Hospital
Conditions:
Respiratory Distress Syndrome, Newborn
Eligibility:
All Genders
Up to 48 years
Phase:
NA
Brief Summary
Surfactant administration via a supraglottic airway device or laryngeal mask airway (SALSA) is a minimally invasive method of instilling surfactant in the trachea during spontaneous breathing and afte...
Detailed Description
Methodology Feasibility will be measure by a combination of real-life observations of the procedure and video-review with synced physiological data (oxygen saturation and heart rate). Study Site The ...
Eligibility Criteria
Inclusion
- Parental informed consent, AND
- Inborn neonate (=born in the hospital), AND
- Gestational age less than 34 + 0 weeks, AND
- Age less than 48 hours, AND
- Birth weight from 750g to 1500g, AND
- Clinical diagnosis of RDS requiring non-invasive respiratory support (CPAP/NIPPV) and fraction of inspired oxygen (FiO2) 0.30-0.60 to maintain oxygen saturation (SpO2) between 90% and 95%.
Exclusion
- Severe respiratory insufficiency in need of emergency intubation
- Previous surfactant administration
- Previous mechanical ventilation
- Known pneumothorax
- Major malformations
- Investigators not available
Key Trial Info
Start Date :
September 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06606444
Start Date
September 20 2024
End Date
August 1 2025
Last Update
August 19 2025
Active Locations (1)
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1
Phu San Hanoi Hospital - Hanoi Obstetrics and Gynecology Hospital
Hanoi, Vietnam, 118000