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低血糖和高血糖与缺氧缺血性脑病婴儿的不良预后相关:CoolCap研究的事后分析

Hypoglycaemia and hyperglycaemia are associated with unfavourable outcome in infants with hypoxic ischaemic encephalopathy: a post hoc analysis of the CoolCap Study.

作者信息

Basu Sudeepta K, Kaiser Jeffrey R, Guffey Danielle, Minard Charles G, Guillet Ronnie, Gunn Alistair J

机构信息

Baylor College of Medicine, Houston, Texas, USA Children's National Medical Center, Washington, DC, USA.

Baylor College of Medicine, Houston, Texas, USA.

出版信息

Arch Dis Child Fetal Neonatal Ed. 2016 Mar;101(2):F149-55. doi: 10.1136/archdischild-2015-308733. Epub 2015 Aug 17.

Abstract

OBJECTIVE

To investigate the association of neonatal hypoglycaemia and hyperglycaemia with outcomes in infants with hypoxic ischaemic encephalopathy (HIE).

DESIGN

Post hoc analysis of the CoolCap Study.

SETTING

25 perinatal centres in the UK, the USA and New Zealand during 1999-2002.

PATIENTS

234 infants at ≥36 weeks' gestation with moderate-to-severe HIE enrolled in the CoolCap Study. 214 (91%) infants had documented plasma glucose and follow-up outcome data.

INTERVENTION

Infants were randomised to head cooling for 72 h starting within 6 h of birth, or standard care. Plasma glucose levels were measured at predetermined time intervals after randomisation.

MAIN OUTCOME MEASURE

The unfavourable primary outcome of the study was death and/or severe neurodevelopmental disability at 18 months. Hypoglycaemia (≤40 mg/dL, ≤2.2 mmol/L) and hyperglycaemia (>150 mg/dL, >8.3 mmol/L) during the first 12 h after randomisation were investigated for univariable and multivariable associations with unfavourable primary outcome.

RESULTS

121 (57%) infants had abnormal plasma glucose values within 12 h of randomisation. Unfavourable outcome was observed in 126 (60%) infants and was more common among subjects with hypoglycaemia (81%, p=0.004), hyperglycaemia (67%, p=0.01) and any glucose derangement within the first 12 h (67%, p=0.002) compared with normoglycaemic infants (48%) in univariable analysis. These associations remained significant after adjusting for birth weight, Apgar score, pH, Sarnat stage and hypothermia therapy.

CONCLUSIONS

Both hypoglycaemia and hyperglycaemia in infants with moderate-to-severe HIE were independently associated with unfavourable outcome. Future studies are needed to investigate the prognostic significance of these associations and their role as biomarkers of brain injury.

TRIAL REGISTRATION NUMBER

(ClinicalTrials.gov NCT00383305).

摘要

目的

探讨新生儿低血糖和高血糖与缺氧缺血性脑病(HIE)患儿预后的关系。

设计

对CoolCap研究进行事后分析。

地点

1999年至2002年期间,英国、美国和新西兰的25个围产期中心。

患者

234例孕周≥36周的中重度HIE患儿纳入CoolCap研究。214例(91%)患儿有血浆葡萄糖记录及随访结局数据。

干预措施

婴儿被随机分为出生后6小时内开始进行72小时头部降温或标准护理。随机分组后按预定时间间隔测量血浆葡萄糖水平。

主要结局指标

该研究的不良主要结局为18个月时死亡和/或严重神经发育障碍。研究随机分组后前12小时内的低血糖(≤40mg/dL,≤2.2mmol/L)和高血糖(>150mg/dL,>8.3mmol/L)与不良主要结局的单变量和多变量相关性。

结果

121例(57%)婴儿在随机分组后12小时内血浆葡萄糖值异常。126例(60%)婴儿出现不良结局,单变量分析显示,与血糖正常的婴儿(48%)相比,低血糖(81%,p=0.004)、高血糖(67%,p=0.01)以及随机分组后前12小时内任何血糖紊乱(67%,p=0.002)的婴儿中不良结局更为常见。在调整出生体重、阿氏评分、pH值、萨纳特分期和低温治疗后,这些相关性仍然显著。

结论

中重度HIE患儿的低血糖和高血糖均与不良结局独立相关。未来需要进一步研究以探讨这些相关性的预后意义及其作为脑损伤生物标志物的作用。

试验注册号

(ClinicalTrials.gov NCT00383305)

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