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Идёт набор NCT06786039

Clinical Impact of Non-invasive Neurally Adjusted Ventilatory Assist in Very Preterm Infants

— Наблюдательное Preterm Infant

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: Non-invasive NAVA.
Кому может быть актуально
Состояния в реестре: Preterm Infant. Базовые параметры: 1 Hour — 48 Hours · 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
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This is a prospective observational study investigating the impact of NIV-NAVA on short-term clinical outcomes and long-term neurodevelopment in very preterm infants.

Вмешательства

  • Процедура Non-invasive NAVA
    Initiate respiratory assist with NIV-NAVA within 48 hours. The setting of respiratory support will be adjusted based on clinical conditions of each subject. NIV-NAVA could be switched to nasal continuous airway pressure or high flow nasal cannula, and it also could be stopped after initial stabilization. In cases of respiratory distress syndrome, lung surfactant will be administered via the less invasive surfactant administration (LISA) method and avoid endotracheal intubation whenever possible

Первичные конечные точки

  • Rate of Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) failure [Срок оценки: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months]
Вторичные конечные точки (12)
  • Rate of bronchopulmonary dysplasia (BPD) [Срок оценки: at 36 weeks of postmenstrual age]
  • Duration of non-invasive ventilation [Срок оценки: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months]
  • Incidence of periventricular leukomalacia (PVL) [Срок оценки: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months]
  • Duration of invasive ventilation [Срок оценки: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months]
  • Incidence of air leaks [Срок оценки: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months]
  • Incidence of patent ductus arteriosus (PDA) [Срок оценки: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months]
  • Time to achieve full enteral feeding [Срок оценки: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months]
  • Incidence of intraventricular hemorrhage (IVH) [Срок оценки: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months]
  • Incidence of retinopathy of prematurity (ROP) [Срок оценки: through the study completion, during the hospital stay in neonatal intensive care unit up to 3 months]
  • Total brain volume (mL) [Срок оценки: term equivalent age defined as 37-42 weeks mean postmenstrual age at brain MRI]
  • Intracranial volume (mL) [Срок оценки: term equivalent age defined as 37-42 weeks mean postmenstrual age at brain MRI]
  • Relative sizes of volumes of particular regions of interest [Срок оценки: term equivalent age defined as 37-42 weeks mean postmenstrual age at brain MRI]

Критерии участия

Критерии включения

  • Preterm infants born between 27 weeks 0 days to 31 weeks 6 days of gestation
  • Preterm infants who require respiratory support within the first 48 hours of life

Критерии исключения

  • Preterm infants who die within the first 48 hours of life
  • Preterm infants who do not require any respiratory support within the first 48 hours of life.
  • Preterm infants with congenital anomalies affecting the lungs, heart, or other organs that could influence breathing
  • Infants whose parents do not consent to participate in the study

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

South Korea · 2 центра
  • Seoul National Bundang Hospital NICU — Seongnam-si
  • Korea University Anam Hospital, NICU — Seoul

Публикации

  • Cho H, Jung YH, Park J, Yang HJ, Kim MJ, Lee J. Feasibility of NIV-NAVA as a primary respiratory support and its clinical impacts in a targeted group of preterm infants: protocol for a prospective observational study. BMJ Open. 2026 Jun 7;16(6):e114353. doi: 10.1136/bmjopen-2025-114353. PMID 42252137

Идентификаторы

NCT: NCT06786039 · 2024AN0554

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗