ISRCTN79705768已完成未知
eurodevelopmental outcome after neonatal hypoglycaemia: a multi-centre randomised controlled trial comparing intensive treatment versus expectant glucose monitoring in 'high risk' newborns
Academic Medical Centre (AMC) (The Netherlands)0 个研究点目标入组 689 人开始时间: 2007年8月23日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 689
研究概览
简要总结
2020 results in https://www.ncbi.nlm.nih.gov/pubmed/32023373 (added 06/02/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as 04/09/2019:
- •Infants greater than or equal to 35 weeks gestational age and greater than or equal to 2000 g with one of the four major risk factors for neonatal hypoglycaemia:
- •1. Small-for-Gestational-Age infants (SGA, birth-weight-for-gestational-age less than P10)
- •2. Large-for-Gestational-Age infants (LGA, birth-weight-for-gestational-age greater than P90)
- •3. Near-term infants 35 0/7 to 36 6/7 weeks gestational age with a birth weight greater than 2000 g
- •4. Infants of Diabetic Mothers (IDM)
- •Birth-weight-for-gestational-age is defined according to the growth charts of the Perinatale Registratie Nederland (PRN).
- •Previous participant inclusion criteria:
- •Infants greater than or equal to 35 weeks gestational age and greater than or equal to 2000 g with one of the four major risk factors for neonatal hypoglycaemia:
- •1. Small-for-Gestational-Age infants (SGA, birth-weight-for-gestational-age less than P10)
- •2. Large-for-Gestational-Age infants (LGA, birth-weight-for-gestational-age greater than P90)
- •3. Near-term infants 35 0/7 to 36 6/7 weeks gestational age with a birth weight greater than 2000 g
- •4. Infants of Diabetic Mothers (IDM)
- •Birth-weight-for-gestational-age is defined according to the Kloosterman growth charts.
排除标准
- •Current participant exclusion criteria:
- •Infants with serious co-morbidity will be excluded, because their co-morbidity can also affect neurodevelopment:
- •1. Very preterm infants (less than 34 6/7 weeks gestational age)
- •2. Severe perinatal asphyxia - presence of at least three of the next criteria:
- •2.1. Signs of intrauterine asphyxia, like late decelerations on Cardiotocogram (CTG) or meconium stained amniotic fluid
- •2.2. Arterial umbilical cord pH less than 7.10
- •2.3. Delayed initiation of spontaneous respirations greater than 5 minutes after birth
- •2.4. Five minute Apgar score less than 5
- •2.5. Multi-organ failure
- •3. Severe perinatal infection: requiring support of vital functions (infants without clinical signs of infection who are treated with antibiotics because of suspected perinatal infection can be included)
- •4. Respiratory insufficiency requiring respiratory support
- •5. Severe hypotension requiring vasopressor support
- •6. (Strong suspicion of) a syndrome or major congenital malformations
- •Other exclusion criteria:
- •7. Intravenous glucose administration before randomization
- •8. (Strong suspicion of) inborn error of metabolism
- •9. (Strong suspicion of) hyperinsulinism, except infants of diabetic mothers
- •10. No informed consent
- •Previous participant exclusion criteria:
- •Infants with serious co-morbidity will be excluded, because their co-morbidity can also affect neurodevelopment:
- •1. Very preterm infants (less than 34 6/7 weeks gestational age)
- •2. Severe perinatal asphyxia - presence of at least three of the next criteria:
- •2.1. Signs of intrauterine asphyxia, like late decelerations on Cardiotocogram (CTG) or meconium stained amniotic fluid
- •2.2. Arterial umbilical cord pH less than 7.10
- •2.3. Delayed initiation of spontaneous respirations greater than 5 minutes after birth
- •2.4. Five minute Apgar score less than 5
- •2.5. Multi-organ failure
- •3. Severe perinatal infection: requiring support of vital functions (infants without clinical signs of infection who are treated with antibiotics because of suspected perinatal infection can be included)
- •4. Respiratory insufficiency requiring respiratory support
- •5. Severe hypotension requiring vasopressor support
- •6. (Strong suspicion of) a syndrome or major congenital malformations
- •Other exclusion criteria:
- •7. (Strong suspicion of) inborn error of metabolism
- •8. (Strong suspicion of) hyperinsulinism, except infants of diabetic mothers
- •9. No informed consent
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