NL-OMON23239已完成不适用
eurodevelopmental outcome after neonatal hypoglycemia: a multi-center randomized controlled trial comparing intensive treatment versus expectant glucose monitoring in 'high risk' newborns.
Academical Medical Center, Amsterdam, The Netherlands0 个研究点目标入组 800 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 800
研究概览
简要总结
Boluyt N, Van Kempen AAMW, Offringa M. Neurodevelopment after neonatal hypoglycemia: a systematic review and design of an optimal future study. Pediatrics. 2006 Jun;117(6):2231-43
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Infants >=35 weeks gestational age and >=2000 gram with one of the four major risk factors for neonatal hypoglycemia:
- •a. Small-for-gestational-age infants (SGA, birth-weight-for-gestational-age b. Large-for-gestational-age infants (LGA, birth-weight-for-gestational-age >P90);
- •c. Near-term infants 35 0/7 to 36 6/7 weeks gestational age with a birth weight >2000 gram;
- •d. Infants of diabetic mothers (IDM).
- •Birth-weight-for-gestational-age is defined according to the growth charts of the Perinatale Registratie Nederland (PRN).
排除标准
- •Infants with serious co-morbidity will be excluded, because their co-morbidity can also affect neurodevelopment:
- •1. Very preterm infants (<34 6/7 weeks gestational age);
- •2. Severe perinatal asphyxia: presence of at least 3 of the next criteria:
- •a. Signs of intrauterine asphyxia, like late decelerations on CTG or meconium stained amniotic fluid
- •b. Arterial umbilical cord pH <7.10
- •c. Delayed initiation of spontaneous respirations >5 minutes after birth
- •d. 5 minute Apgar score <5;
- •e. 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.
研究者
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