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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-28
SponsorIstanbul University - Cerrahpasa

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

Infants requiring intubation

Presence of congenital anomalies

Pre-existing nasal injury or trauma

Presence of skin disease

Trial design

Treatments tested in this trial

  • Binasal Prong
  • Nasal Cannula
  • Nasal Mask

Treatment groups

75 Participants
are divided into 3 treatment groups