低血糖症用葡萄糖凝胶治疗 4.5 年后的结局：Sugar Babies 随机试验的随访。
Outcome at 4.5 years after dextrose gel treatment of hypoglycaemia: follow-up of the Sugar Babies randomised trial.
机构信息
School of Nursing Midwifery and Health Practice, Victoria University of Wellington, Wellington, New Zealand.
Liggins Institute, The University of Auckland, Auckland, New Zealand.
出版信息
Arch Dis Child Fetal Neonatal Ed. 2023 Mar;108(2):121-128. doi: 10.1136/archdischild-2022-324148. Epub 2022 Aug 8.
OBJECTIVE
Dextrose gel is used to treat neonatal hypoglycaemia, but later effects are unknown.
DESIGN AND SETTING
Follow-up of participants in a randomised trial recruited in a tertiary centre and assessed in a research clinic.
PATIENTS
Children who were hypoglycaemic (<2.6 mmol/L) recruited to the Sugar Babies Study (35 weeks, <48 hours old) and randomised to treatment with 40% dextrose or placebo gel.
INTERVENTIONS
Assessment of neurological status, cognitive ability (Weschler Preschool and Primary Scale of Intelligence), executive function (five tasks), motor function (Movement Assessment Battery for Children-2 (MABC-2)), vision, visual processing (Beery-Buktenica Development Test of Visual Motor Integration (Beery VMI) and motion coherence thresholds) and growth at 2 years.
MAIN OUTCOME MEASURES
Neurosensory impairment (cerebral palsy; visual impairment; deafness; intelligence quotient <85; Beery VMI <85; MABC-2 score <15th centile; low performance on executive function or motion coherence).
RESULTS
Of 237 babies randomised, 185 (78%) were assessed; 96 randomised to dextrose and 89 to placebo gel. Neurosensory impairment was similar in both groups (dextrose 36/96 (38%) vs placebo 34/87 (39%), relative risk 0.96, 95% CI 0.66 to 1.34, p=0.83). Secondary outcomes were also similar, except children randomised to dextrose had worse visual processing scores (mean (SD) 94.5 (15.9) vs 99.8 (15.9), p=0.02) but no differences in the proportion with visual processing scores <85 or other visual test scores. Children randomised to dextrose gel were taller (z-scores 0.18 (0.97) vs -0.17 (1.01), p=0.001) and heavier (0.57 (1.07) vs 0.29 (0.92), p=0.01).
CONCLUSIONS
Treatment of neonatal hypoglycaemia (<2.6 mol/L) with dextrose gel does not alter neurosensory impairment at 4.5 years. However, further assessment of visual processing and growth may be warranted.
TRIAL REGISTRATION NUMBER
ACTRN1260800062392.
目的
葡萄糖凝胶用于治疗新生儿低血糖症，但后期效果尚不清楚。
设计和设置
在一家三级中心招募并在研究诊所评估的随机试验参与者的随访。
患者
低血糖（<2.6mmol/L）的婴儿参加了糖宝宝研究（35 周，<48 小时），并随机分配接受 40%葡萄糖或安慰剂凝胶治疗。
干预措施
评估神经状态、认知能力（韦氏学龄前和小学智力量表）、执行功能（五项任务）、运动功能（儿童运动评估电池-2（MABC-2））、视力、视觉处理（比耶尔-布克蒂卡发展测试视觉运动整合（比耶尔 VMI）和运动连贯性阈值）以及 2 岁时的生长。
主要观察指标
感觉神经损伤（脑瘫；视力障碍；耳聋；智商<85；比耶尔 VMI<85；MABC-2 评分<第 15 百分位；执行功能或运动连贯性低）。
结果
在 237 名随机分配的婴儿中，有 185 名（78%）接受了评估；96 名随机分配接受葡萄糖，89 名接受安慰剂凝胶。两组感觉神经损伤相似（葡萄糖组 36/96（38%）与安慰剂组 34/87（39%），相对风险 0.96，95%CI0.66 至 1.34，p=0.83）。次要结局也相似，除了随机接受葡萄糖的儿童视觉处理评分较差（平均（SD）94.5（15.9）与 99.8（15.9），p=0.02），但视觉处理评分<85 或其他视觉测试评分的比例无差异。随机接受葡萄糖凝胶的儿童身高较高（Z 分数 0.18（0.97）与-0.17（1.01），p=0.001）和体重较重（0.57（1.07）与 0.29（0.92），p=0.01）。
结论
新生儿低血糖症（<2.6mol/L）用葡萄糖凝胶治疗不会改变 4.5 岁时的感觉神经损伤。然而，可能需要进一步评估视觉处理和生长。
试验注册号
ACTRN1260800062392。
Zotero 插件