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临床试验/ACTRN12614001263684
ACTRN12614001263684进行中(未招募)3 期

In newborn infants at risk of hypoglycaemia does prophylactic oral dextrose gel compared to placebo reduce admission to Newborn Intensive Care Unit (NICU).

niversity of Auckland0 个研究点目标入组 2,149 人开始时间: 2014年12月3日最近更新:
适应症

试验速览

阶段
3 期
状态
进行中(未招募)
入组人数
2,149

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Prevention
盲法
Blinded (masking used)

入排标准

年龄范围
Hours 至 1 Hours(—)
性别
All

入选标准

  • Babies who are at risk of hypoglycaemia, defined as satisfying AT LEAST ONE of the following:
  • 1. Infants of diabetic mothers (any type of diabetes)
  • 2. Preterm (< 37 weeks' gestation)
  • 3. Small (< 2.5kg or < 10th centile on population or customised birthweight chart)
  • 4. Large (> 4.5kg or > 90th centile on population or customised birthweight chart)
  • AND satisfy ALL of the following:
  • 1. > or = 35+0 weeks' gestation
  • 2. Birthweight > or = 2.2kg
  • 3. < 1 hour old
  • 4. No apparent indication for NICU/SCBU admission at time of randomisation
  • 5. Unlikely to require admission to NICU/SCBU for any other reason e.g. respiratory distress
  • 6. Mother intending to breastfeed

排除标准

  • 1. Major congenital abnormality
  • 2. Previous formula feed or intravenous fluids
  • 3. Previous diagnosis of hypoglycaemia
  • 4. Admitted to NICU/SCBU
  • 5. Imminent admission to NICU/SCB

研究者

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