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

NCT07521410 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-04-16

No results posted yet for this study

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

Conditions

  • Medical Device-Related Pressure Injury
  • Prematurity

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.

Sponsors & Collaborators

  • Istanbul University - Cerrahpasa

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Minutes
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-20
Primary Completion
2026-04-24
Completion
2026-10-24

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07521410 on ClinicalTrials.gov