De-implementing Inhaled Nitric Oxide for Congenital Diaphragmatic Hernia
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: Inhaled Nitric Oxide (iNO) use, De-implementation of Inhaled Nitric Oxide (iNO) use.
- Кому может быть актуально
- Состояния в реестре: Congenital Diaphragmatic Hernia. Базовые параметры: 0 мес. — 1 мес. · 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
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Inhaled Nitric Oxide (iNO) for Congenital Diaphragmatic Hernia (CDH) - The "NoNO Trial" - a Multi-center, De-implementation, Stepped-wedge, Cluster-randomized Trial Within an Established Collaborative
Обзор
The purpose of this study is to determine if de-implementation of inhaled nitric oxide (iNO) in the post-natal resuscitation/stabilization phase affects the composite outcome of extracorporeal life support (ECLS) use and/or mortality, as well as ECLS use, mortality, and/or oxygenation in congenital diaphragmatic hernia (CDH) newborns and to establish the cost-effectiveness of de-implementing iNO as a therapy in the postnatal resuscitation/stabilization phase of CDH management, which will be assessed as the incremental health system costs (savings) per prevented ECLS use and/or death.
Подробное описание
In this multi-center study, centers will use iNO per their usual protocol, and centers will then crossover to iNO de-implementation (that is, at the time of crossover, centers will stop using iNO in the initial resuscitation period). A stepped-wedge crossover study design will be used, and the timing of crossover will be cluster randomized at the level of the center.
Вмешательства
- Препарат Inhaled Nitric Oxide (iNO) use
The center will use iNO per their usual protocol in the initial resuscitation period (defined as birth through stabilization and CDH repair). No center will alter any component of their standard clinical practice guideline or protocol governing CDH care. - Другое De-implementation of Inhaled Nitric Oxide (iNO) use
The center will stop using iNO in the initial resuscitation period (defined as birth through stabilization and CDH repair).
Первичные конечные точки
- Number of participants who require Extracorporeal Life Support (ECLS) and/or who die prior to discharge [Срок оценки: from birth through hospital discharge (up to 12 months from birth)]
Вторичные конечные точки (5)
- Number of participants who require Extracorporeal Life Support (ECLS) prior to discharge [Срок оценки: from birth through hospital discharge (up to 12 months from birth)]
- Number of participants who die prior to discharge [Срок оценки: from birth through hospital discharge (up to 12 months from birth)]
- Change in oxygenation [Срок оценки: 1 hour after initiation of iNO use]
- Change in oxygenation [Срок оценки: 6 hours after initiation of iNO use]
- Total cost of initial inpatient care from birth through hospital discharge, per center [Срок оценки: from birth through hospital discharge (up to 12 months from birth)]
Критерии участия
Критерии включения
- Postnatal, live born neonates with CDH
a. Presence of associated or additional anomalies is acceptable for inclusion
- Bochdalek hernia location (right or left)
- Diagnosed prior to 1 month of life
- Born within or transferred to (within 1 week of life) a CDHSG member center participating in the trial
Критерии исключения
- CDH diagnosis after 1 month of age
- Morgagni diaphragmatic hernia (central / anterior-medial diaphragmatic defect location)
- Transferred to a CDH Study Group (CDHSG) member center after 1 week of life
- Patients without potential access to iNO
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 19 центров
- University of Alabama & Children's Hospital of Alabama (UAB-CoA) — Birmingham
- University of Arkansas & Arkansas Children's Hospital (UA-ACH) — Little Rock
- University of California-Irvine & Children's Hospital of Orange County (UC-CHOC) — Irvine
- University of Southern California & Children's Hospital Los Angeles (USC-CHLA) — Los Angeles
- Stanford University & Lucile Packard Children's Hospital (Stanford-LPCH) — Palo Alto
- University of California, San Diego & Rady Children's Hospital (UCSD-Rady) — San Diego
- University of Colorado & Children's Hospital of Colorado (CU-CHC) — Aurora
- Emory University & Children's Healthcare of Atlanta (CHOA) — Atlanta
- … и ещё 11 центров
Идентификаторы
NCT: NCT05213676 · HSC-MS-21-0603