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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Binasal Prong | Experimental | Preterm infants receiving non-invasive ventilation support via binasal prong interface. |
|
| Nasal Cannula | Experimental | Preterm infants receiving non-invasive ventilation support via nasal cannula interface. |
|
| Nasal Mask | Experimental | Preterm infants receiving non-invasive ventilation support via nasal mask interface. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Binasal Prong | Device | Continuous positive airway pressure (CPAP) delivered via binasal prong interface. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Medical Device-Related Nasal Pressure Injury | Occurrence of medical device-related nasal pressure injury in preterm infants receiving non-invasive ventilation, assessed using a standardized pressure injury staging scale. | Within 96 hours (4 days) after initiation of non-invasive ventilation |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Nasal Pressure Injury | Severity of nasal pressure injury assessed using a standardized pressure injury staging scale. | Every 12 hours for 96 hours |
| Nasal Skin Condition | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esra CUMUR BAÅžKIR | Contact | +90 541 680 21 59 | cumuresra@ogr.iuc.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tekirdag Ismail Fehmi Cumalioglu City Hospital, Neonatal Intensive Care Unit | Tekirdağ | Turkey (Türkiye) |
Individual participant data will not be shared due to ethical and legal restrictions regarding the confidentiality of neonatal patient data and institutional policies.
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000072601 | Cannula |
| ID | Term |
|---|---|
| D057785 | Catheters |
| D004864 | Equipment and Supplies |
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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.
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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.
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| Nasal Cannula | Device | Continuous positive airway pressure (CPAP) delivered via nasal cannula. |
|
| Nasal Mask | Device | Continuous positive airway pressure (CPAP) delivered via nasal mask interface. |
|
| Every 12 hours for 96 hours |
| Risk of Skin Injury | 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. | Every 12 hours for 96 hours |
| D000091642 | Urogenital Diseases |