Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants: a protocol for the SafeBoosC randomised clinical phase III trial
Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants: a protocol for the SafeBoosC randomised clinical phase III trial
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DOI：
10.1186/s13063-019-3955-6
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发表时间：
2019-12-30
期刊：
影响因子：
2.5
通讯作者：
Greisen, Gorm
中科院分区：
文献类型：
--
作者：
Hansen, Mathias Luhr;Pellicer, Adelina;Greisen, Gorm
背景：脑氧合监测可能会降低极早产儿死亡和神经系统并发症的风险，但在充分有效的随机临床试验中，尚未在早产儿中证明这种效果。SafeBoosC III试验的目的是调查基于近红外光谱(NIRS)监测的治疗与常规治疗相比对极早产儿的益处和危害。方法/设计：SafeBoosC III是一项由研究人员发起的跨国、随机、实用的III期临床试验。纳入标准将是月经后28周以下出生的婴儿以及父母知情同意(除非网站使用的是选择退出或延期同意)。排除标准将是：没有父母知情同意(或者如果使用‘选择退出’，没有临床工作人员向父母解释试验和‘选择退出’同意过程的记录和/或婴儿临床档案中父母决定退出的记录)；决定不提供全面的生命支持；以及不可能在出生后6小时内启动脑NIRS血氧检测。参与者将按1：1随机分为试验组或控制组。试验组的参与者将在生命的前72小时内使用大脑近红外血氧仪进行监测。脑缺氧将按照循证治疗指南进行治疗。对照组参与者不接受脑氧合监测，照常接受治疗。每个参与者都将在月经后36周进行随访。主要结果将是在这些婴儿的月经后36周内进行常规头颅超声扫描，检测到死亡或严重脑损伤的综合结果。严重的脑损伤将由一名对分组盲人进行评估。为了检测试验组和对照组之间22%的相对风险差异，我们打算对1600名婴儿进行随机队列。讨论：在脑NIRS血氧仪指导下进行治疗有可能降低早产儿严重脑损伤后死亡或存活的风险。目前迫切需要评估近红外光谱监测在早产儿中的临床效果。
Background: Cerebral oxygenation monitoring may reduce the risk of death and neurologic complications in extremely preterm infants, but no such effects have yet been demonstrated in preterm infants in sufficiently powered randomised clinical trials. The objective of the SafeBoosC III trial is to investigate the benefits and harms of treatment based on near-infrared spectroscopy (NIRS) monitoring compared with treatment as usual for extremely preterm infants.Methods/design: SafeBoosC III is an investigator-initiated, multinational, randomised, pragmatic phase III clinical trial. Inclusion criteria will be infants born below 28 weeks postmenstrual age and parental informed consent (unless the site is using 'opt-out' or deferred consent). Exclusion criteria will be no parental informed consent (or if 'opt-out' is used, lack of a record that clinical staff have explained the trial and the 'opt-out' consent process to parents and/or a record of the parents' decision to opt-out in the infant's clinical file); decision not to provide full life support; and no possibility to initiate cerebral NIRS oximetry within 6 h after birth. Participants will be randomised 1:1 into either the experimental or control group. Participants in the experimental group will be monitored during the first 72 h of life with a cerebral NIRS oximeter. Cerebral hypoxia will be treated according to an evidence-based treatment guideline. Participants in the control group will not undergo cerebral oxygenation monitoring and will receive treatment as usual. Each participant will be followed up at 36 weeks postmenstrual age. The primary outcome will be a composite of either death or severe brain injury detected on any of the serial cranial ultrasound scans that are routinely performed in these infants up to 36 weeks postmenstrual age. Severe brain injury will be assessed by a person blinded to group allocation. To detect a 22% relative risk difference between the experimental and control group, we intend to randomise a cohort of 1600 infants.Discussion: Treatment guided by cerebral NIRS oximetry has the potential to decrease the risk of death or survival with severe brain injury in preterm infants. There is an urgent need to assess the clinical effects of NIRS monitoring among preterm neonates.