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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 19
- 主要终点
- Number of participants who require Extracorporeal Life Support (ECLS) and/or who die prior to discharge
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Months 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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).
干预措施: De-implementation of Inhaled Nitric Oxide (iNO) use (Other)
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.
干预措施: Inhaled Nitric Oxide (iNO) use (Drug)
结局指标
主要结局
Number of participants who require Extracorporeal Life Support (ECLS) and/or who die prior to discharge
时间窗: from birth through hospital discharge (up to 12 months from birth)
The primary outcome is the composite outcome of ECLS use and/or mortality.
次要结局
- Change in oxygenation(6 hours after initiation of iNO use)
- Number of participants who require Extracorporeal Life Support (ECLS) prior to discharge(from birth through hospital discharge (up to 12 months from birth))
- Number of participants who die prior to discharge(from birth through hospital discharge (up to 12 months from birth))
- Change in oxygenation(1 hour after initiation of iNO use)
- Total cost of initial inpatient care from birth through hospital discharge, per center(from birth through hospital discharge (up to 12 months from birth))
研究者
Matthew T Harting
Associate Professor
The University of Texas Health Science Center, Houston