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).
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
