GALOP: Oral Glibenclamide in premature hyperglycemia - P160916J

Assistance Publique Hopitaux De Paris0 个研究点目标入组 45 人开始时间: 2024年6月7日最近更新: 2024年7月22日

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•Newborn less than 34 weeks post-mentrual age, -Birth weight < 1500 g, -Gestational age < 32 weeks, -Hyperglycaemia = 10 mmol/l on 2 measurements taken at least 3 hours apart after eventual reduction of glucose intakes following each unit’s protocol (if not consecutive, within a maximum interval of 9 hours), -Secure venous access point (umbilical venous catheter or epicutaneo-cava catheter), -Enteral feeding considered or already started prior to enrolment, -Consent obtained from legal guardians, -Beneficiary of social security

•-Contraindication to enteral feeding (at the discretion of the clinician responsible for the child), -Patient with continuous insulin IV administration, -Patient treated with miconazole, -Small for gestational age: birth weight < 3rd percentile (AUDIPOG definition), -Severe birth defect, including cardiac malformation associated with a risk of myocardial ischemia, -Severe sepsis requiring mechanical ventilation or haemodynamic support, -Severe renal dysfunction (serum creatinine > 120 µmol/l), -Severe hepatocellular failure (if assessment indicated: V factor less than the standard laboratory range for the age) and/or severe cholestasis (conjugated bilirubin > 50 µmol/L), -Hyperglycaemia associated with an error in administering glucose infusion, -Profound hypophosphoremia (< 1 mmol/l), -Hypersensitivity to glibenclamide or other sulphonylureas or sulphonamides, or one of the excipients

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