GALOP : Oral glibenclamide in hyperglycaemia of the premature infant

Phase 1

Conditions: Transient hyperglycaemia in premature infants
MedDRA version: 24.1Level: LLTClassification code: 10086431Term: Neonatal hyperglycemia Class: 100000004848
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: CTIS2024-512230-15-00

Lead Sponsor: Assistance Publique Hopitaux De Paris

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 45

Inclusion Criteria

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

Exclusion Criteria

-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