The TOBY Study. Whole body hypothermia for the treatment of perinatal asphyxial encephalopathy: a randomised controlled trial.
The TOBY Study. Whole body hypothermia for the treatment of perinatal asphyxial encephalopathy: a randomised controlled trial.
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DOI：
10.1186/1471-2431-8-17
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发表时间：
2008-04-30
期刊：
影响因子：
2.4
通讯作者：
TOBY Study Group
中科院分区：
文献类型：
--
作者：
Azzopardi D;Brocklehurst P;Edwards D;Halliday H;Levene M;Thoresen M;Whitelaw A;TOBY Study Group
出生前后发生的缺氧-缺血性损伤可能导致脑病状态，其特征是出生时需要复苏、神经抑郁、癫痫发作和脑电异常。脑病越严重，死亡或神经发育异常的风险就越大。目前的治疗措施包括将生理参数维持在正常范围内，并使用抗惊厥药物治疗癫痫。对成年和新生动物的研究表明，脑损伤后体温降低3-4摄氏度与组织学和行为结果的改善有关。报道了头部降温联合全身亚低温和中度全身降温至33.5℃的婴幼儿脑病的初步研究。没有注意到并发症，但小组规模太小，无法评估益处。Toby是一项多中心、前瞻性、随机的研究，对围产期窒息后的足月儿进行研究，比较那些被分配到“重症监护加全身降温72小时”的婴儿和那些被分配到“没有降温的重症监护”的足月儿。足月儿将在出生后6小时内随机分为对照组，直肠温度保持在37+/-0.2°C，或全身降温，直肠温度保持在33-34°C，持续72小时。有中度或重度脑病+/-癫痫征象的足月儿，通过脑功能监测确认其资格。结果将在18个月大时使用神经学和神经发育测试方法进行评估。至少需要236名婴儿，才能证明18个月时死亡或严重残疾的相对风险降低了30%。征聘工作比目标提前了七个月，并获得了批准，使征聘工作得以继续进行到计划的征聘阶段结束。共招募了325名婴儿。18个月大的幸存者的死亡率和严重神经发育障碍的综合比率。神经发育障碍将被定义为以下任何一种：·贝利智力发育量表评分低于70分·粗大运动功能分类系统III-V级·双侧皮质视觉障碍当前对照试验ISRCTN89547571
A hypoxic-ischaemic insult occurring around the time of birth may result in an encephalopathic state characterised by the need for resuscitation at birth, neurological depression, seizures and electroencephalographic abnormalities. There is an increasing risk of death or neurodevelopmental abnormalities with more severe encephalopathy. Current management consists of maintaining physiological parameters within the normal range and treating seizures with anticonvulsants. Studies in adult and newborn animals have shown that a reduction of body temperature of 3–4°C after cerebral insults is associated with improved histological and behavioural outcome. Pilot studies in infants with encephalopathy of head cooling combined with mild whole body hypothermia and of moderate whole body cooling to 33.5°C have been reported. No complications were noted but the group sizes were too small to evaluate benefit. TOBY is a multi-centre, prospective, randomised study of term infants after perinatal asphyxia comparing those allocated to "intensive care plus total body cooling for 72 hours" with those allocated to "intensive care without cooling". Full-term infants will be randomised within 6 hours of birth to either a control group with the rectal temperature kept at 37 +/- 0.2°C or to whole body cooling, with rectal temperature kept at 33–34°C for 72 hours. Term infants showing signs of moderate or severe encephalopathy +/- seizures have their eligibility confirmed by cerebral function monitoring. Outcomes will be assessed at 18 months of age using neurological and neurodevelopmental testing methods. At least 236 infants would be needed to demonstrate a 30% reduction in the relative risk of mortality or serious disability at 18 months. Recruitment was ahead of target by seven months and approvals were obtained allowing recruitment to continue to the end of the planned recruitment phase. 325 infants were recruited. Combined rate of mortality and severe neurodevelopmental impairment in survivors at 18 months of age. Neurodevelopmental impairment will be defined as any of: • Bayley mental developmental scale score less than 70 • Gross Motor Function Classification System Levels III – V • Bilateral cortical visual impairments Current Controlled Trials ISRCTN89547571
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影响因子：
8.3
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