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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

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

Study 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

Eligibility

Primary outcome measure(s)

• Incidence of Medical Device-Related Nasal Pressure Injury — 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.

Trial sites (1)

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