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NOT YET RECRUITING
NCT07521410
NA

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

Sponsor: Istanbul University - Cerrahpasa

View on ClinicalTrials.gov

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

DEVICE

Binasal Prong

Continuous positive airway pressure (CPAP) delivered via binasal prong interface.

DEVICE

Nasal Cannula

Continuous positive airway pressure (CPAP) delivered via nasal cannula.

DEVICE

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)