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).
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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