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Not yet recruiting NCT07521410

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

No phase Interventional Medical Device-Related Pressure Injury Prematurity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Binasal Prong, Nasal Cannula, Nasal Mask.
Who it may be relevant to
Registry conditions: Medical Device-Related Pressure Injury, Prematurity. Basic parameters: 0 Minutes — 28 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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

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.

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.

Primary outcome measures

  • Incidence of Medical Device-Related Nasal Pressure Injury [Time frame: Within 96 hours (4 days) after initiation of non-invasive ventilation]
Secondary outcome measures (3)
  • Severity of Nasal Pressure Injury [Time frame: Every 12 hours for 96 hours]
  • Nasal Skin Condition [Time frame: Every 12 hours for 96 hours]
  • Risk of Skin Injury [Time frame: Every 12 hours for 96 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Turkey (Türkiye) · 1 center
  • Tekirdag Ismail Fehmi Cumalioglu City Hospital, Neonatal Intensive Care Unit — Tekirdağ

Identifiers

NCT: NCT07521410 · İstanbul U-Cerrahpaşa

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗