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