Clinical Trial

Non-Invasive Ventilation Interfaces and Nasal Pressure Injury in Preterm Infants

Study acronym: NIV-MDRPI
Not Yet Recruiting
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Record status
This record was last updated April 16, 2026 (before its estimated April 24, 2026 completion). Its status may not reflect the trial's current state.
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
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-04-03.
Trial Details
NCT Number NCT07521410
Lead Sponsor Istanbul University - Cerrahpasa
Conditions Medical Device-Related Pressure Injury, Prematurity
Enrollment 75 participants
Start Date 2026-04-20
Primary Completion 2026-04-24 (estimated)
Study Completion 2026-10-24 (estimated)
Updated on ClinicalTrials.gov 2026-04-16