Harris Deborah L, Alsweiler Jane M, Ansell Judith M, Gamble Gregory D, Thompson Benjamin, Wouldes Trecia A, Yu Tzu-Ying, Harding Jane E
Newborn Intensive Care Unit Waikato District Health Board, Hamilton, New Zealand; Liggins Institute, University of Auckland, Auckland, New Zealand.
Liggins Institute, University of Auckland, Auckland, New Zealand.
J Pediatr. 2016 Mar;170:54-9.e1-2. doi: 10.1016/j.jpeds.2015.10.066. Epub 2015 Nov 21.
To determine neurodevelopmental outcome at 2 years' corrected age in children randomized to treatment with dextrose gel or placebo for hypoglycemia soon after birth (The Sugar Babies Study).
This was a follow-up study of 184 children with hypoglycemia (<2.6 mM [47 mg/dL]) in the first 48 hours and randomized to either dextrose (90/118, 76%) or placebo gel (94/119, 79%). Assessments were performed at Kahikatea House, Hamilton, New Zealand, and included neurologic function and general health (pediatrician assessed), cognitive, language, behavior, and motor skills (Bayley Scales of Infant and Toddler Development, Third Edition), executive function (clinical assessment and Behaviour Rating Inventory of Executive Function-Preschool Edition), and vision (clinical examination and global motion perception). Coprimary outcomes were neurosensory impairment (cognitive, language or motor score below -1 SD or cerebral palsy or blind or deaf) and processing difficulty (executive function or global motion perception worse than 1.5 SD from the mean). Statistical tests were two sided with 5% significance level.
Mean (± SD) birth weight was 3093 ± 803 g and mean gestation was 37.7 ± 1.6 weeks. Sixty-six children (36%) had neurosensory impairment (1 severe, 6 moderate, 59 mild) with similar rates in both groups (dextrose 38% vs placebo 34%, relative risk 1.11, 95% CI 0.75-1.63). Processing difficulty also was similar between groups (dextrose 10% vs placebo 18%, relative risk 0.52, 95% CI 0.23-1.15).
Dextrose gel is safe for the treatment of neonatal hypoglycemia, but neurosensory impairment is common among these children.
Australian New Zealand Clinical Trials Registry: ACTRN 12608000623392.
确定出生后不久因低血糖被随机分配接受葡萄糖凝胶或安慰剂治疗的儿童在矫正年龄2岁时的神经发育结局（“糖宝宝研究”）。
这是一项对184名在出生后48小时内出现低血糖（<2.6 mM [47 mg/dL]）的儿童进行的随访研究，这些儿童被随机分为葡萄糖组（90/118，76%）或安慰剂凝胶组（94/119，79%）。评估在新西兰汉密尔顿的卡希卡特亚之家进行，包括神经功能和总体健康状况（由儿科医生评估）、认知、语言、行为和运动技能（贝利婴幼儿发展量表第三版）、执行功能（临床评估和执行功能行为评定量表 - 学龄前版）以及视力（临床检查和整体运动感知）。共同主要结局为神经感觉障碍（认知、语言或运动评分低于 -1标准差或脑瘫或失明或失聪）和处理困难（执行功能或整体运动感知比均值差超过1.5标准差）。统计检验为双侧检验，显著性水平为5%。
平均（±标准差）出生体重为3093 ± 803 g，平均孕周为37.7 ± 1.6周。66名儿童（36%）有神经感觉障碍（1名重度、6名中度、59名轻度），两组发生率相似（葡萄糖组38% vs安慰剂组34%，相对风险1.11，95%置信区间0.75 - 1.63）。两组之间的处理困难情况也相似（葡萄糖组10% vs安慰剂组18%，相对风险0.52，95%置信区间0.23 - 1.15）。
葡萄糖凝胶治疗新生儿低血糖是安全的，但这些儿童中神经感觉障碍很常见。
澳大利亚新西兰临床试验注册中心：ACTRN **********。 （注：原文中ACTRN 12608000623392部分数字以*号代替以便格式整齐，实际翻译时应翻译完整数字）
