Department of Neonatology, Copenhagen University Hospital ─ Rigshospitalet, Copenhagen, Denmark.
Copenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital ─ Rigshospitalet, Copenhagen, Denmark.
Trials. 2023 Oct 28;24(1):696. doi: 10.1186/s13063-023-07699-x.
The SafeBoosC project aims to test the clinical value of non-invasive cerebral oximetry by near-infrared spectroscopy in newborn infants. The purpose is to establish whether cerebral oximetry can be used to save newborn infants' lives and brains or not. Newborns contribute heavily to total childhood mortality and neonatal brain damage is the cause of a large part of handicaps such as cerebral palsy. The objective of the SafeBoosC-IIIv trial is to evaluate the benefits and harms of cerebral oximetry added to usual care versus usual care in mechanically ventilated newborns.
METHODS/DESIGN: SafeBoosC-IIIv is an investigator-initiated, multinational, randomised, pragmatic phase-III clinical trial. The inclusion criteria will be newborns with a gestational age more than 28 + 0 weeks, postnatal age less than 28 days, predicted to require mechanical ventilation for at least 24 h, and prior informed consent from the parents or deferred consent or absence of opt-out. The exclusion criteria will be no available cerebral oximeter, suspicion of or confirmed brain injury or disorder, or congenital heart disease likely to require surgery. A total of 3000 participants will be randomised in 60 neonatal intensive care units from 16 countries, in a 1:1 allocation ratio to cerebral oximetry versus usual care. Participants in the cerebral oximetry group will undergo cerebral oximetry monitoring during mechanical ventilation in the neonatal intensive care unit for as long as deemed useful by the treating physician or until 28 days of life. The participants in the cerebral oximetry group will be treated according to the SafeBoosC treatment guideline. Participants in the usual care group will not receive cerebral oximetry and will receive usual care. We use two co-primary outcomes: (1) a composite of death from any cause or moderate to severe neurodevelopmental disability at 2 years of corrected age and (2) the non-verbal cognitive score of the Parent Report of Children's Abilities-Revised (PARCA-R) at 2 years of corrected age.
There is need for a randomised clinical trial to evaluate cerebral oximetry added to usual care versus usual care in mechanically ventilated newborns.
The protocol is registered at www.
gov (NCT05907317; registered 18 June 2023).
SafeBoosC 项目旨在通过近红外光谱法测试新生儿无创脑氧饱和度的临床价值。目的是确定脑氧饱和度是否可以用于拯救新生儿的生命和大脑。新生儿在儿童总死亡率中占比很大，新生儿脑损伤是脑瘫等大部分残疾的原因。SafeBoosC-IIIv 试验的目的是评估机械通气新生儿中常规护理加脑氧饱和度与常规护理相比的益处和危害。
方法/设计：SafeBoosC-IIIv 是一项由研究者发起的、多中心、随机、实用的 III 期临床试验。纳入标准为胎龄大于 28+0 周、生后年龄小于 28 天、预计需要机械通气至少 24 小时、且父母事先知情同意或延期同意或无退出意愿的新生儿。排除标准为无可用脑氧饱和度仪、疑似或确诊脑损伤或障碍、或可能需要手术的先天性心脏病。将从 16 个国家的 60 个新生儿重症监护病房共招募 3000 名参与者，以 1:1 的比例随机分配至脑氧饱和度组与常规护理组。脑氧饱和度组的参与者将在新生儿重症监护病房接受机械通气期间进行脑氧饱和度监测，由治疗医生决定监测时间，或直至 28 天的生命。脑氧饱和度组的参与者将按照 SafeBoosC 治疗指南进行治疗。常规护理组的参与者将不接受脑氧饱和度监测，接受常规护理。我们使用两个主要结局指标：（1）校正年龄 2 岁时任何原因死亡或中重度神经发育障碍的复合结局；（2）校正年龄 2 岁时家长报告儿童能力修订版（PARCA-R）的非语言认知评分。
需要进行一项随机临床试验，评估机械通气新生儿中常规护理加脑氧饱和度与常规护理相比的效果。
该方案在 www. 上注册（NCT05907317；于 2023 年 6 月 18 日注册）。
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