Oral Glibenclamide in Premature Hyperglycaemia (GALOP)

The purpose of this study is to confirm hypothesis that Glibenclamide can be administered orally and is an alternative to insulin therapy in treating transient hyperglycemia of premature newborns.

Inclusion Criteria:Newborn less than 34 week of amenorrhea corrected ageBirth weight < 1500 gBirth term < 32 week of amenorrheaHyperglycemia ≥ 10 mmol/l in 2 measurements, 3 hours apart after potential reduction of glucose intakes following each department's protocolSecure venous access point (umbilical venous catheter or epicutaneo-cava catheter)Enteral feeding considered before inclusion or already establishedConsent obtained from persons holding parental authorityBeneficiary of social securityExclusion CriteriaContraindication to enteral feeding (at the discretion of the clinician responsible for the child)Contraindication to glibenclamide according to current SPCFoetal growth restriction (FGR) birth weight < 3rd percentile (AUDIPOG definition)Severe birth defect, including cardiac malformation associated with a risk of myocardial ischemiaSevere sepsis requiring mechanical ventilation or haemodynamic supportSevere renal dysfunction (serum creatinine > 120 µmol/l)Severe hepatocellular failure (V factor less than the standard laboratory range for the age) and/or severe cholestasis (> 50 µmol/L)Hyperglycemia associated with an error in administering glucose infusionProfound hypophosphoremia (< 1 mmol/l)Hypersensitivity to glibenclamide or other sulphonylureas or sulphonamides, or one of the excipientsPatient with continuous insulin IV administrationPatient treated with miconazole