EURODEVELOPMENTAL OUTCOME AFTER NEONATAL HYPOGLYCEMIA: A MULTI-CENTER RANDOMIZED CONTROLLED TRIAL COMPARING INTENSIVE TREATMENT VERSUS EXPECTANT GLUCOSE MONITORING IN 'HIGH RISK' NEWBORNS. - HYPO EXIT: HYPOglycemia: EXpectant versus Intensive Therapy

Academisch Medisch Centrum0 个研究点目标入组 800 人开始时间: 待定最近更新: 2024年5月13日

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•Infants with one of the four major risk factors for neonatal hypoglycemia, who are routinely screened for neonatal hypoglycemia in current clinical practice:
•1. Small-for-gestational-age infants (SGA, birth-weight-for-gestational-age 2. Large-for-gestational-age infants (LGA, birth-weight-for-gestational-age >P90);
•3. Near-term infants 35 0/7 to 36 6/7 weeks gestational age with a birth weight >2000 gram;
•4. Infants of diabetic mothers (IDM).
•Birth-weight-for-gestational-age is defined according to the Kloosterman growth charts.

•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
•3. Severe perinatal infection
•4. Respiratory insufficiency
•5. Severe hypotension
•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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