Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv): Cerebral Oximetry Versus Usual Care in Mechanically Ventilated Newborns
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,610
- 试验地点
- 1
- 主要终点
- Hospital-free days within 90 days of randomisation
研究概览
简要总结
The objective of the SafeBoosC-IIIv trial is to assess benefits and harms of cerebral oximetry in newborns receiving invasive mechanical ventilation. The hypothesis is that:
i. Cerebral oximetry added to usual care versus usual care alone in newborns receiving invasive mechanical ventilation will increase the number of hospital-free days within 90 days of randomisation.
ii. The intervention will decrease a composite outcome of death or moderate to severe neurodevelopmental disability and/or increase the mean PARCA-R non-verbal cognitive score at two years of corrected age.
详细描述
SafeBoosC-IIIv will be an investigator-initiated, multinational, randomised, pragmatic phase III clinical trial. The trial will be conducted in two steps. In step one, 1,610 newborns will be randomised, and the outcomes will be assessed 90 days after randomisation. Funding has been obtained for step one. If further funding is obtained, we will continue to include newborns until a total of 3,000 newborns are randomised and then follow them up at two years of corrected age (step two).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Step one: The primary outcome will be assessed by a blinded investigator. The principal investigator from each centre must develop a local blinding procedure, describing how blinding is achieved. To support the principal investigators in this work, a Standard Operation Procedure with suggestions for blinding procedures will be developed. Data managers, statisticians, and conclusion drawers will be blinded.
Step two: Due to the nature of the experimental intervention, clinical staff and the parents will not be blinded to group allocation. Thus, the primary outcome will not be blinded in cases when it relies on parental reporting. If there is no contact with the parents, or if they do not return the questionnaire, data will be collected from health care records. Investigators reviewing the health care records will, if possible, be blinded to the allocated intervention. Data managers, statisticians, and conclusion drawers will be blinded.
入排标准
- 年龄范围
- 0 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age more than or equal to 28+0
- •Postnatal age less than 28 days
- •Expected to receive invasive mechanical ventilation (intubation) for at least 24 hours, as judged by the physician intending to randomise
- •Parental informed consent unless the centre has chosen to use 'opt-out' or deferred consent as consent method
- •A cerebral oximeter available so monitoring can be started within six hours after initiation of invasive mechanical ventilation
排除标准
- •Suspicion of or confirmed brain injury or disorder (e.g. severe hypoxic-ischemic encephalopathy, intraventricular haemorrhage grade 3 or 4, cerebral malformation, genetic or metabolic disease)
- •Suspicion or diagnosis of congenital heart malformations likely to require surgery
结局指标
主要结局
Hospital-free days within 90 days of randomisation
时间窗: 90 days
Primary outcome for step one
Parental questionnaires
时间窗: 18-30 months
Co-primary outcome for step two: Parental questionnaires completed between 18-30 months' corrected age as well as available data from at least 12 months' corrected age from health care records, including standardised neurodevelopmental assessments, will be used to assess mortality and neurodevelopment. • Non-verbal cognitive score of Parent Report of Children's Abilities-Revised (PARCA-R), a parental questionnaire, at two years of corrected age (range 0-34, higher score means better outcome).
A composite of death from any cause or moderate to severe neurodevelopmental disability
时间窗: 2 years
Co-primary outcome for step two A composite of death from any cause or moderate to severe neurodevelopmental disability at two years of corrected age. Moderate to severe neurodevelopmental disability will be defined as one or more of the following 1. cerebral palsy with Global Motor Function Classification System level 2 or higher; 2. a Parent Report of Children's Abilities-Revised (PARCA-R) non-verbal cognitive function score (range 0-34, higher score means better outcome) below -2 standard deviations (SD); 3. hearing loss corrected with aids or worse; or 4. vision impairment defined as moderately reduced vision of one eye, or only being able to perceive light or light reflecting objects; or blind in one eye with good vision in the contralateral eye.
次要结局
- Invasive mechanical ventilation-free days within 90 days of randomisation(90 days)
- Proportion of participants with a serious adverse event(90 days)