Gunn Alistair J, Wyatt John S, Whitelaw Andrew, Barks John, Azzopardi Denis, Ballard Roberta, Edwards A David, Ferriero Donna M, Gluckman Peter D, Polin Richard A, Robertson Charlene M, Thoresen Marianne
Department of Physiology, University of Auckland, Auckland, New Zealand.
J Pediatr. 2008 Jan;152(1):55-8, 58.e1. doi: 10.1016/j.jpeds.2007.06.003. Epub 2007 Oct 24.
To evaluate whether therapeutic hypothermia alters the prognostic value of clinical grading of neonatal encephalopathy.
This study was a secondary analysis of a multicenter study of 234 term infants with neonatal encephalopathy randomized to head cooling for 72 hours starting within 6 hours of birth, with rectal temperature maintained at 34.5 degrees C +/- 0.5 degrees C, followed by re-warming for 4 hours, or standard care at 37.0 degrees C +/- 0.5 degrees C. Severity of encephalopathy was measured pre-randomization and on day 4, after re-warming, in 177 infants; 31 infants died before day 4, and data were missing for 10 infants. The primary outcome was death or severe disability at 18 months of age.
Milder pre-randomization encephalopathy, greater improvement in encephalopathy from randomization to day 4, and cooling were associated with favorable outcome in multivariate binary logistic regression. Hypothermia did not affect severity of encephalopathy at day 4, however, in infants with moderate encephalopathy at day 4, those treated with hypothermia had a significantly higher rate of favorable outcome (31/45 infants, 69%, P = .006) compared with standard care (12/33, 36%).
Infants with moderate encephalopathy on day 4 may have a more favorable prognosis after hypothermia treatment than expected after standard care.
评估治疗性低温是否会改变新生儿脑病临床分级的预后价值。
本研究是一项多中心研究的二次分析，该多中心研究纳入了234名足月新生儿脑病患儿，这些患儿被随机分为两组，一组在出生后6小时内开始进行72小时的头部降温，直肠温度维持在34.5摄氏度±0.5摄氏度，随后进行4小时的复温；另一组接受37.0摄氏度±0.5摄氏度的标准护理。在随机分组前以及复温后的第4天，对177名婴儿的脑病严重程度进行了测量；31名婴儿在第4天前死亡，10名婴儿的数据缺失。主要结局是18个月时的死亡或严重残疾。
在多变量二元逻辑回归分析中，随机分组前较轻的脑病、从随机分组到第4天脑病的更大改善以及降温与良好结局相关。然而，低温并未影响第4天的脑病严重程度，不过，在第4天患有中度脑病的婴儿中，接受低温治疗的婴儿与接受标准护理的婴儿相比，良好结局的发生率显著更高（45名婴儿中有31名，69%，P = 0.006）（33名婴儿中有12名，36%）。
第4天患有中度脑病的婴儿在接受低温治疗后的预后可能比接受标准护理后的预期更有利。
