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

Istanbul University - Cerrahpasa

Status: Begins enrollment this month

Conditions: Prematurity; Medical Device-Related Pressure Injury

Treatments: Device: Nasal Cannula; Device: Binasal Prong; Device: Nasal Mask

Study type: Interventional

Funder types: Other

Identifiers

NCT07521410

İstanbul U-Cerrahpaşa

Details and patient eligibility

About

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

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Binasal Prong

Experimental group

Description:

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

Treatment:

Device: Binasal Prong

Nasal Cannula

Experimental group

Description:

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

Treatment:

Device: Nasal Cannula

Nasal Mask

Experimental group

Description:

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

Treatment:

Device: Nasal Mask