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Набор скоро начнётся NCT07521410

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

Без фазы С лечением Medical Device-Related Pressure Injury Prematurity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Binasal Prong, Nasal Cannula, Nasal Mask.
Кому может быть актуально
Состояния в реестре: Medical Device-Related Pressure Injury, Prematurity. Базовые параметры: 0 Minutes — 28 Days · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
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Официальное название

Comparison of the Effects of Different Non-Invasive Ventilation Interfaces on the Development of Medical Device-Related Nasal Pressure Injury in Preterm Infants

Обзор

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

Подробное описание

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.

Вмешательства

  • Устройство Binasal Prong
    Continuous positive airway pressure (CPAP) delivered via binasal prong interface.
  • Устройство Nasal Cannula
    Continuous positive airway pressure (CPAP) delivered via nasal cannula.
  • Устройство Nasal Mask
    Continuous positive airway pressure (CPAP) delivered via nasal mask interface.

Первичные конечные точки

  • Incidence of Medical Device-Related Nasal Pressure Injury [Срок оценки: Within 96 hours (4 days) after initiation of non-invasive ventilation]
Вторичные конечные точки (3)
  • Severity of Nasal Pressure Injury [Срок оценки: Every 12 hours for 96 hours]
  • Nasal Skin Condition [Срок оценки: Every 12 hours for 96 hours]
  • Risk of Skin Injury [Срок оценки: Every 12 hours for 96 hours]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Turkey (Türkiye) · 1 центр
  • Tekirdag Ismail Fehmi Cumalioglu City Hospital, Neonatal Intensive Care Unit — Tekirdağ

Идентификаторы

NCT: NCT07521410 · İstanbul U-Cerrahpaşa

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗