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

NCT07521410 | Not Yet Recruiting

• 1 other identifier: İstanbul U-Cerrahpaşa
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Prematurity; Medical Device-Related Pressure Injury

Keywords

Preterm infants; Non-invasive ventilation; Nasal pressure injury; Medical device-related pressure injury; Neonatal intensive care unit; CPAP; Nasal interface

Outcome Measures

Primary Outcomes (1)

• Incidence of Medical Device-Related Nasal Pressure Injury

  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 Outcomes (3)

• Severity of Nasal Pressure Injury

  Every 12 hours for 96 hours

• Nasal Skin Condition

  Every 12 hours for 96 hours

• Risk of Skin Injury

  Every 12 hours for 96 hours

Study Arms (3)

Binasal Prong

EXPERIMENTAL

Preterm infants receiving non-invasive ventilation support via binasal prong interface.

Device: Binasal Prong

Nasal Cannula

EXPERIMENTAL

Preterm infants receiving non-invasive ventilation support via nasal cannula interface.

Device: Nasal Cannula

Nasal Mask

EXPERIMENTAL

Preterm infants receiving non-invasive ventilation support via nasal mask interface.

Device: Nasal Mask

Interventions

Binasal Prong DEVICE

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

Binasal Prong

Nasal Cannula DEVICE

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

Nasal Cannula

Nasal Mask DEVICE

Continuous positive airway pressure (CPAP) delivered via nasal mask interface.

Nasal Mask

Eligibility Criteria

• Age: 0 Minutes - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Tekirdag Ismail Fehmi Cumalioglu City Hospital, Neonatal Intensive Care Unit

Tekirdağ, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Cannula

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Central Study Contacts

Esra CUMUR BAŞKIR

CONTACT

+90 541 680 21 59; cumuresra@ogr.iuc.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Outcome assessments will be performed by the responsible researcher and an independent neonatal intensive care unit charge nurse. Because the intervention assignment is known during assessment, the study is open label.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned to one of three parallel groups (binasal prong, nasal cannula, or nasal mask) to compare their effects on the development of nasal pressure injury in preterm infants receiving non-invasive ventilation.

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 9, 2026
• Study Start: April 20, 2026
• Primary Completion: April 24, 2026
• Study Completion (Estimated): October 24, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)