Non-Invasive Ventilation Interfaces and Nasal Pressure Injury in Preterm Infants (NIV-MDRPI)

April 13, 2026 updated by: Esra Cumur Baskir, Istanbul University - Cerrahpasa

Comparison of the Effects of Different Non-Invasive Ventilation Interfaces on the Development of Medical Device-Related Nasal Pressure Injury in Preterm Infants

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study focuses on medical device-related nasal pressure injury in preterm infants receiving non-invasive ventilation in neonatal intensive care units. Preterm infants are particularly vulnerable to skin injury due to the immaturity of their skin structure and the increased need for respiratory support. Non-invasive ventilation is widely used to reduce lung injury; however, the use of nasal interfaces may lead to pressure-related skin damage, especially in the nasal area.

Previous studies have shown that non-invasive ventilation itself is a risk factor for nasal pressure injury. The type of interface used, such as binasal prong, nasal cannula, or nasal mask, may influence the frequency and severity of these injuries. However, evidence comparing the effectiveness of different interfaces in preventing nasal pressure injury remains limited.

This study is designed as a prospective, randomized controlled trial with a parallel-group design. Preterm infants receiving non-invasive ventilation will be randomly assigned to one of three interface groups: binasal prong, nasal cannula, or nasal mask. Skin condition, pressure injury development, and risk levels will be evaluated using standardized assessment tools, including the Neonatal Skin Risk Assessment Scale (NSRAS), Neonatal Skin Condition Score (NSCS), and Pressure Injury Staging Scale (PISS).

The findings of this study are expected to contribute to evidence-based neonatal nursing care by supporting clinical decision-making in the selection of appropriate ventilation interfaces and improving preventive care strategies for pressure injury in neonatal intensive care units.

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
      • Tekirdağ, Turkey (Türkiye)
        • Tekirdag Ismail Fehmi Cumalioglu City Hospital, Neonatal Intensive Care Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Preterm infants with a gestational age between 28 and 37 weeks
  • Receiving non-invasive ventilation support in a neonatal intensive care unit
  • Receiving non-invasive ventilation for at least 4 days
  • Parental consent obtained

Exclusion Criteria:

  • Infants requiring intubation
  • Presence of congenital anomalies
  • Pre-existing nasal injury or trauma
  • Presence of skin disease
  • Nasal lesions due to previous nasotracheal intubation
  • Upper airway malformations
  • Infants transferred from another center after receiving more than 24 hours of non-invasive ventilation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Binasal Prong
Preterm infants receiving non-invasive ventilation support via binasal prong interface.
Device: Binasal Prong
Continuous positive airway pressure (CPAP) delivered via binasal prong interface.
Experimental: Nasal Cannula
Preterm infants receiving non-invasive ventilation support via nasal cannula interface.
Device: Nasal Cannula
Continuous positive airway pressure (CPAP) delivered via nasal cannula.
Experimental: Nasal Mask
Preterm infants receiving non-invasive ventilation support via nasal mask interface.
Device: Nasal Mask
Continuous positive airway pressure (CPAP) delivered via nasal mask interface.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Medical Device-Related Nasal Pressure Injury
Time Frame: Within 96 hours (4 days) after initiation of non-invasive ventilation
Occurrence of medical device-related nasal pressure injury in preterm infants receiving non-invasive ventilation, assessed using a standardized pressure injury staging scale.
Within 96 hours (4 days) after initiation of non-invasive ventilation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of Nasal Pressure Injury
Time Frame: Every 12 hours for 96 hours
Severity of nasal pressure injury assessed using a standardized pressure injury staging scale.
Every 12 hours for 96 hours
Nasal Skin Condition
Time Frame: Every 12 hours for 96 hours
Assessment of nasal skin condition using the Neonatal Skin Condition Score (NSCS), which evaluates dryness, erythema, and skin breakdown. The total score ranges from 3 to 9, with higher scores indicating worse skin condition.
Every 12 hours for 96 hours
Risk of Skin Injury
Time Frame: Every 12 hours for 96 hours
Evaluation of the risk of skin injury using the Neonatal Skin Risk Assessment Scale (NSRAS). The total score ranges from 6 to 24, with lower scores indicating higher risk of skin injury.
Every 12 hours for 96 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 20, 2026

Primary Completion (Estimated)

April 24, 2026

Study Completion (Estimated)

October 24, 2026

Study Registration Dates

First Submitted

April 3, 2026

First Submitted That Met QC Criteria

April 3, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • İstanbul U-Cerrahpaşa

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to ethical and legal restrictions regarding the confidentiality of neonatal patient data and institutional policies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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