Objective To investigate the effect of different doses of prophylactic dextrose gel on neurocognitive function and health at 6–7 years. Design Early school-age follow-up of the pre-hPOD (hypoglycaemia Prevention with Oral Dextrose) study. Setting Schools and communities. Patients Children born at ≥35 weeks with ≥1 risk factor for neonatal hypoglycaemia: maternal diabetes, small or large for gestational age, or late preterm. Interventions Four interventions commencing at 1 hour of age: dextrose gel (40%) 200 mg/kg; 400 mg/kg; 200 mg/kg and 200 mg/kg repeated before three feeds (800 mg/kg); 400 mg/kg and 200 mg/kg before three feeds (1000 mg/kg); compared with equivolume placebo (combined for analysis). Main outcomes measures Toolbox cognitive and motor batteries, as well as tests of motion perception, numeracy and cardiometabolic health, were used. The primary outcome was neurocognitive impairment, defined as a standard score of more than 1 SD below the age-corrected mean on one or more Toolbox tests. Findings Of 392 eligible children, 309 were assessed for the primary outcome. There were no significant differences in the rate of neurocognitive impairment between those randomised to placebo (56%) and dextrose gel (200 mg/kg 46%: adjusted risk difference (aRD)=−14%, 95% CI −35%, 7%; 400 mg/kg 48%: aRD=−7%, 95% CI −27%, 12%; 800 mg/kg 45%: aRD=−14%, 95% CI −36%, 9%; 1000 mg/kg 50%: aRD=−8%, 95% CI −29%, 13%). Children exposed to any dose of dextrose gel (combined), compared with placebo, had a lower risk of motor impairment (3% vs 14%, aRD=-11%, 95% CI −19%, −3%) and higher mean (SD) cognitive scores (106.0 (15.3) vs 101.1 (15.7), adjusted mean difference=5.4, 95% CI 1.8, 8.9). Conclusions Prophylactic neonatal dextrose gel did not alter neurocognitive impairment at early school age but may have motor and cognitive benefits. Further school-age follow-up studies are needed. Data are available upon reasonable request. Deidentified individual participant data (including data dictionaries) will be made available, in addition to study protocols, the statistical analysis plan and the informed consent form. The data will be made available upon publication to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal, according to the data sharing protocol of The University of Auckland (). Proposals should be submitted to dataservices@auckland.ac.nz.

中文翻译：

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葡萄糖凝胶预防学龄早期新生儿低血糖和神经认知功能：随机剂量试验

目的探讨不同剂量预防性葡萄糖凝胶对6~7岁儿童神经认知功能和健康的影响。设计 hPOD（口服葡萄糖预防低血糖）研究的早期学龄随访。设置学校和社区。患者 ≥35 周出生且具有≥1 个新生儿低血糖危险因素的儿童：母亲糖尿病、小于胎龄或大于胎龄、或晚期早产。干预措施 四项干预措施从 1 小时龄开始：葡萄糖凝胶 (40%) 200 mg/kg； 400毫克/公斤； 3 次喂食前重复 200 mg/kg 和 200 mg/kg（800 mg/kg）； 3次喂食前400毫克/公斤和200毫克/公斤（1000毫克/公斤）；与等体积安慰剂相比（合并进行分析）。主要结果测量工具箱认知和运动电池，以及运动感知、计算能力和心脏代谢健康的测试。主要结局是神经认知障碍，定义为在一项或多项 Toolbox 测试中标准得分低于年龄校正平均值 1 SD 以上。结果 在 392 名符合条件的儿童中，有 309 名接受了主要结局评估。随机分配到安慰剂组 (56%) 和葡萄糖凝胶组 (200 mg/kg 46%: 调整后风险差 (aRD)=−14%, 95% CI -35%, 7 组的神经认知障碍发生率没有显着差异%; 400 mg/kg 48%: aRD=−7%, 95% CI −27%, 12%; 800 mg/kg 45%: aRD=−14%, 95% CI −36%, 9%; 1000 mg /kg 50%：aRD=-8%，95% CI -29%，13%）。与安慰剂相比，暴露于任何剂量的葡萄糖凝胶（组合）的儿童运动障碍的风险较低（3% vs 14%，aRD=-11%，95% CI -19%，-3%）且平均值较高(SD) 认知评分（106.0 (15.3) 与 101.1 (15.7)，调整后平均差 = 5.4，95% CI 1.8、8.9）。结论 预防性新生儿葡萄糖凝胶不会改变学龄早期的神经认知障碍，但可能具有运动和认知方面的益处。需要进一步的学龄随访研究。数据可根据合理要求提供。除了研究方案、统计分析计划和知情同意书之外，还将提供未识别的个人参与者数据（包括数据字典）。根据奥克兰大学的数据共享协议（）。提案应提交至 dataservices@auckland.ac.nz。