Liggins Institute, University of Auckland, Auckland, New Zealand.
Newborn Services, Auckland City Hospital, Auckland, New Zealand.
PLoS Med. 2021 Jan 28;18(1):e1003411. doi: 10.1371/journal.pmed.1003411. eCollection 2021 Jan.
Neonatal hypoglycemia is common and can cause brain injury. Buccal dextrose gel is effective for treatment of neonatal hypoglycemia, and when used for prevention may reduce the incidence of hypoglycemia in babies at risk, but its clinical utility remains uncertain.
We conducted a multicenter, double-blinded, placebo-controlled randomized trial in 18 New Zealand and Australian maternity hospitals from January 2015 to May 2019. Babies at risk of neonatal hypoglycemia (maternal diabetes, late preterm, or high or low birthweight) without indications for neonatal intensive care unit (NICU) admission were randomized to 0.5 ml/kg buccal 40% dextrose or placebo gel at 1 hour of age. Primary outcome was NICU admission, with power to detect a 4% absolute reduction. Secondary outcomes included hypoglycemia, NICU admission for hypoglycemia, hyperglycemia, breastfeeding at discharge, formula feeding at 6 weeks, and maternal satisfaction. Families and clinical and study staff were unaware of treatment allocation. A total of 2,149 babies were randomized (48.7% girls). NICU admission occurred for 111/1,070 (10.4%) randomized to dextrose gel and 100/1,063 (9.4%) randomized to placebo (adjusted relative risk [aRR] 1.10; 95% CI 0.86, 1.42; p = 0.44). Babies randomized to dextrose gel were less likely to become hypoglycemic (blood glucose < 2.6 mmol/l) (399/1,070, 37%, versus 448/1,063, 42%; aRR 0.88; 95% CI 0.80, 0.98; p = 0.02) although NICU admission for hypoglycemia was similar between groups (65/1,070, 6.1%, versus 48/1,063, 4.5%; aRR 1.35; 95% CI 0.94, 1.94; p = 0.10). There were no differences between groups in breastfeeding at discharge from hospital (aRR 1.00; 95% CI 0.99, 1.02; p = 0.67), receipt of formula before discharge (aRR 0.99; 95% CI 0.92, 1.08; p = 0.90), and formula feeding at 6 weeks (aRR 1.01; 95% CI 0.93, 1.10; p = 0.81), and there was no hyperglycemia. Most mothers (95%) would recommend the study to friends. No adverse effects, including 2 deaths in each group, were attributable to dextrose gel. Limitations of this study included that most participants (81%) were infants of mothers with diabetes, which may limit generalizability, and a less reliable analyzer was used in 16.5% of glucose measurements.
In this placebo-controlled randomized trial, prophylactic dextrose gel 200 mg/kg did not reduce NICU admission in babies at risk of hypoglycemia but did reduce hypoglycemia. Long-term follow-up is needed to determine the clinical utility of this strategy.
ACTRN 12614001263684.
新生儿低血糖症较为常见，可导致脑损伤。口腔葡萄糖凝胶对新生儿低血糖症的治疗有效，用于预防时可能会降低有低血糖风险的婴儿的低血糖发生率，但其实用性仍不确定。
我们在 2015 年 1 月至 2019 年 5 月期间在新西兰和澳大利亚的 18 家产科医院进行了一项多中心、双盲、安慰剂对照随机试验。有发生新生儿低血糖风险（母亲患有糖尿病、晚期早产儿或出生体重过高或过低）但无入住新生儿重症监护病房（NICU）指征的婴儿，在出生后 1 小时随机接受 0.5ml/kg 口腔 40%葡萄糖或安慰剂凝胶。主要结局是 NICU 入院，有足够的效能检测到 4%的绝对减少。次要结局包括低血糖、因低血糖而入住 NICU、高血糖、出院时母乳喂养、6 周时配方奶喂养以及母亲满意度。家庭和临床及研究人员对治疗分配不知情。共有 2149 名婴儿被随机分组（48.7%为女孩）。1070 名随机分配至葡萄糖凝胶组中有 111 名（10.4%）入住 NICU，1063 名随机分配至安慰剂组中有 100 名（9.4%）入住 NICU（调整后的相对风险 [aRR]1.10；95%CI0.86，1.42；p=0.44）。与安慰剂组相比，随机分配至葡萄糖凝胶组的婴儿发生低血糖（血糖<2.6mmol/l）的可能性更小（399/1070，37%，vs.448/1063，42%；aRR0.88；95%CI0.80，0.98；p=0.02），但两组因低血糖而入住 NICU 的情况相似（65/1070，6.1%，vs.48/1063，4.5%；aRR1.35；95%CI0.94，1.94；p=0.10）。两组出院时母乳喂养（aRR1.00；95%CI0.99，1.02；p=0.67）、出院前接受配方奶喂养（aRR0.99；95%CI0.92，1.08；p=0.90）以及 6 周时配方奶喂养（aRR1.01；95%CI0.93，1.10；p=0.81）均无差异，且均未出现高血糖。大多数母亲（95%）会向朋友推荐该研究。没有不良反应，每组各有 2 例死亡，但都与葡萄糖凝胶无关。本研究的局限性包括大多数参与者（81%）为患有糖尿病的母亲的婴儿，这可能限制了其普遍性，且 16.5%的葡萄糖测量使用了不太可靠的分析仪。
在这项安慰剂对照随机试验中，预防性给予 200mg/kg 葡萄糖凝胶并不能降低低血糖风险婴儿的 NICU 入院率，但确实能减少低血糖的发生。需要进行长期随访以确定该策略的临床实用性。
ACTRN12614001263684。
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