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Идёт набор NCT05446272

The Diaphragmatic Initiated Ventilatory Assist (DIVA) Trial

Без фазы С лечением Extubation Failure Bronchopulmonary Dysplasia Death

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: NIV-NAVA, NS-NIPPV.
Кому может быть актуально
Состояния в реестре: Extubation Failure, Bronchopulmonary Dysplasia, Death. Базовые параметры: 0 Days — 9 Weeks · 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
США, Канада
Следующий шаг
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Обзор

DIVA is a pragmatic randomized clinical trial (RCT) to determine: among (P) preterm infants born 23 0/7-28 6/7 weeks gestation undergoing extubation from mechanical ventilation, whether (I) Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) (C) compared with Non-synchronized nasal intermittent positive pressure ventilation (NS-NIPPV), will reduce the incidence of (O) extubation failure within (T) 5 days (120 hours) of extubation.

Подробное описание

Bronchopulmonary dysplasia (BPD) is the most common complication of prematurity and is the leading respiratory cause of childhood morbidity. Ventilator induced lung injury (VILI) an accepted and important contributor to BPD. Exposure to oxygen and positive pressure ventilation leads to developmental arrest and parenchymal injury in the immature preterm lung. Because even brief exposure to intubated positive pressure ventilation is injurious, avoiding invasive mechanical ventilation is the most widely acknowledged strategy to prevent VILI and the long-term sequela of BPD. Therefore, time on ventilators and rates of successful extubation are important endpoints of therapy.

Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) is an FDA approved technology that consistently synchronizes non-invasive respiratory support with infant respiratory drive. The Diaphragmatic Initiated Ventilatory Assist (DIVA) trial is an unblinded, pragmatic, multicenter phase III randomized clinical trial in extremely preterm infants 23 0/7- 28 6/7 weeks gestational age to determine if NIV-NAVA, compared with non-synchronized nasal intermittent positive pressure ventilation (NS-NIPPV), prevents extubation failure within 5 days (120 hours) of extubation from mechanical ventilation

Вмешательства

  • Устройство NIV-NAVA
    Infants in the intervention arm will be managed with non-invasive neurally adjusted ventilatory assist (NIV-NAVA) using FDA-approved servos with associated FDA-approved Edi catheter.
  • Устройство NS-NIPPV
    Infants in the active comparator arm will be treated with non-synchronized non-invasive positive pressure ventilation (NIPPV) through FDA-approved ventilators currently in use at each site.

Первичные конечные точки

  • Extubation failure [Срок оценки: within the first 5 days (120 hours) post extubation]
Вторичные конечные точки (7)
  • Bronchopulmonary Dysplasia (BPD) at 36 weeks PMA [Срок оценки: 36 weeks PMA]
  • Death or BPD at 36 weeks PMA [Срок оценки: 36 weeks PMA]
  • Endotracheal intubation through 36 weeks PMA [Срок оценки: 36 weeks PMA]
  • Postmenstrual age at last invasive ventilation [Срок оценки: 36 weeks PMA]
  • Postmenstrual age at last positive pressure support [Срок оценки: 36 weeks PMA]
  • Postmenstrual age at last supplemental oxygen [Срок оценки: 36 weeks PMA]
  • Prematurity-related morbidities through 36 weeks PMA [Срок оценки: 36 weeks PMA]

Критерии участия

Критерии включения

  • Gestational age of 23 0/7- 28 6/7 weeks at birth
  • Intubated in the first 7 days of life
  • Undergoing extubation following at least 12 hours of invasive mechanical ventilation
  • Post-natal age <32 weeks Post menstrual age at time of extubation

Критерии исключения

  • Major congenital anomalies, including pulmonary hypoplasia
  • Neurologic disorders affecting respiratory drive (other than apnea of prematurity)
  • Esophageal bleeding or other contraindication to NG/OG catheter placement
  • Current weight <500 grams (based on Edi catheter approval)
  • Study ventilator not available at time eligibility criteria are met
  • Planned surgery or invasive procedure within 5 days of extubation
  • Informed consent not provided

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
Простое слепое
Основная цель
Лечение

Центры проведения

США · 17 центров
  • Arkansas Children's Hospital — Little Rock
  • Loma Linda University — Loma Linda
  • Sharp Mary Birch — San Diego
  • Joe DiMaggio Children's Hospital — Hollywood
  • AdventHealth — Orlando
  • Peyton Manning Children's Hospital — Indianapolis
  • Norton Children's Hospital — Louisville
  • Children's Mercy Hospital — Kansas City
  • … и ещё 9 центров
Канада · 3 центра
  • Sunnybrook Health Sciences Centre — Toronto
  • Mt Sinai Hospital — Toronto
  • BC Children's and Women's Hospital — Vancouver

Публикации

  • Matlock DN, Ratcliffe SJ, Courtney SE, Kirpalani H, Firestone K, Stein H, Dysart K, Warren K, Goldstein MR, Lund KC, Natarajan A, Demissie E, Foglia EE. The Diaphragmatic Initiated Ventilatory Assist (DIVA) trial: study protocol for a randomized controlled trial comparing rates of extubation failure in extremely premature infants undergoing extubation to non-invasive neurally adjusted ventilatory PMID 38509583

Идентификаторы

NCT: NCT05446272 · 849912

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗