Oral Glibenclamide in Preterm Infants With Hyperglycaemia (GALOP) (GALOP)
Transient; Hypoglycemia, Neonatal, Preterm, Glibenclamide Adverse Reaction
About this trial
This is an interventional treatment trial for Transient; Hypoglycemia, Neonatal focused on measuring transient hypoglycemia, preterm, glibenclamide
Eligibility Criteria
Inclusion Criteria: Newborn less than 34 week of amenorrhea corrected age Birth weight < 1500 g Birth term < 32 week of amenorrhea Hyperglycemia ≥ 10 mmol/l in 2 measurements, 3 hours apart after potential reduction of glucose intakes following each department's protocol Secure venous access point (umbilical venous catheter or epicutaneo-cava catheter) Enteral feeding considered before inclusion or already established Consent obtained from persons holding parental authority Beneficiary of social security Exclusion Criteria Contraindication to enteral feeding (at the discretion of the clinician responsible for the child) Contraindication to glibenclamide according to current SPC Foetal growth restriction (FGR) 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 (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 infusion Profound hypophosphoremia (< 1 mmol/l) Hypersensitivity to glibenclamide or other sulphonylureas or sulphonamides, or one of the excipients Patient with continuous insulin IV administration Patient treated with miconazole
Sites / Locations
- Hopital Necker - Enfants maladesRecruiting
Arms of the Study
Arm 1
Experimental
Glibenclamide oral
Amglidia®: glibenclamide oral suspension 6 mg/ml administered by gastric tube after dilution to 1/6th in human milk