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临床试验/ACTRN12613000322730
ACTRN12613000322730进行中(未招募)3 期

In newborn infants at risk of hypoglycaemia does prophylactic oral dextrose gel compared to placebo reduce the incidence of hypoglycaemia (any blood glucose concentration < 2.6 mM).

niversity of Auckland0 个研究点目标入组 416 人开始时间: 2013年3月22日最近更新:

试验速览

阶段
3 期
状态
进行中(未招募)
发起方
入组人数
416

研究概览

简要总结

Babies who received any dose of dextrose gel were less likely to develop hypoglycaemia than those who received placebo. A single dose of 200mg/kg dextrose gel was most effective and best tolerated. Rates of NICU admission were similar, but admission for hypoglycaemia was less common in babies randomised to dextrose gel. Rates of breastfeeding were similar in both groups. Adverse effects were uncommon and not different between groups. At two years of age there was no difference between any of the groups in the risk of neurosensory impairment or low executive function, or in any of the secondary outcomes. Prophylactic dextrose gel appears safe to two years' corrected age, but this study was underpowered to detect potentially clinically important effects on neurosensory outcomes.

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)
  • 5. Other risk e.g. maternal medication
  • AND satisfy ALL of the following:
  • 1. > or = 35+0 weeks' gestation
  • 2. Birthweight > 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

发起方
niversity of Auckland

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