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Non-Invasive Ventilation Interfaces and Nasal Pressure Injury in Preterm Infants
Sponsor: Istanbul University - Cerrahpasa
Summary
The goal of this randomized controlled clinical trial is to learn whether different non-invasive ventilation interfaces can prevent medical device-related nasal pressure injury in preterm infants receiving respiratory support in a neonatal intensive care unit. The main questions it aims to answer are: * Do different non-invasive ventilation interfaces affect how often nasal pressure injury develops? * Do these interfaces affect the severity of nasal pressure injury and the condition of the nasal skin? Researchers will compare three types of non-invasive ventilation interfaces (binasal prong, nasal cannula, and nasal mask) to see if one method is more effective in reducing nasal pressure injury. Participants will: * Be randomly assigned to one of three groups (binasal prong, nasal cannula, or nasal mask) * Receive non-invasive ventilation support using the assigned interface for at least 4 days * Have their nasal skin assessed every 12 hours for 96 hours using standardized scales * Continue to receive routine care in the neonatal intensive care unit
Official title: Comparison of the Effects of Different Non-Invasive Ventilation Interfaces on the Development of Medical Device-Related Nasal Pressure Injury in Preterm Infants
Key Details
Gender
All
Age Range
0 Minutes - 28 Days
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2026-04-20
Completion Date
2026-10-24
Last Updated
2026-04-09
Healthy Volunteers
No
Interventions
Binasal Prong
Continuous positive airway pressure (CPAP) delivered via binasal prong interface.
Nasal Cannula
Continuous positive airway pressure (CPAP) delivered via nasal cannula.
Nasal Mask
Continuous positive airway pressure (CPAP) delivered via nasal mask interface.
Locations (1)
Tekirdag Ismail Fehmi Cumalioglu City Hospital, Neonatal Intensive Care Unit
Tekirdağ, Turkey (Türkiye)