Oral Glibenclamide in Premature Hyperglycaemia (GALOP)

• Status: Not yet recruiting
• Trial end date: 2026-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Glyburide

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