Medical Device-Related Pressure Injury, Prematurity
Conditions
Keywords
Preterm infants, Non-invasive ventilation, Nasal pressure injury, Medical device-related pressure injury, Neonatal intensive care unit, CPAP, Nasal interface
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
Detailed 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.
Interventions
DEVICEBinasal Prong
Continuous positive airway pressure (CPAP) delivered via binasal prong interface.
DEVICENasal Cannula
Continuous positive airway pressure (CPAP) delivered via nasal cannula.
DEVICENasal Mask
Continuous positive airway pressure (CPAP) delivered via nasal mask interface.
Sponsors
Istanbul University - Cerrahpasa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
0 Years to 28 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Nasal Pressure Injury | Every 12 hours for 96 hours | Severity of nasal pressure injury assessed using a standardized pressure injury staging scale. |
| Nasal Skin Condition | Every 12 hours for 96 hours | Assessment of nasal skin condition using the Neonatal Skin Condition Score (NSCS), which evaluates dryness, erythema, and skin breakdown. The total score ranges from 3 to 9, with higher scores indicating worse skin condition. |
| Risk of Skin Injury | Every 12 hours for 96 hours | Evaluation of the risk of skin injury using the Neonatal Skin Risk Assessment Scale (NSRAS). The total score ranges from 6 to 24, with lower scores indicating higher risk of skin injury. |
Countries
Turkey (Türkiye)
Contacts
CONTACTEsra CUMUR BAŞKIR
Outcome results
None listed