Oral Glibenclamide in Preterm Infants with Hyperglycaemia (GALOP)

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jan 6, 2023

Keywords

ClinConnect Summary

The GALOP clinical trial is looking at a medication called Glibenclamide to see if it can be safely given by mouth to help treat high blood sugar levels, known as hyperglycemia, in premature infants. This study is specifically for newborns who are less than 34 weeks old and weigh less than 1500 grams at birth. To qualify, these babies must have experienced high blood sugar levels on two separate occasions, and they need to be getting some form of feeding. Parents or guardians must also provide consent for their babies to participate.

If your baby is eligible and joins the trial, they will receive Glibenclamide instead of insulin, which is another common treatment for high blood sugar. Throughout the trial, doctors will monitor the babies closely to ensure their safety and health. It’s important to note that some babies may not be able to participate due to certain medical conditions, such as severe infections or specific birth defects. If you have any questions or need more information about this trial, please talk to your healthcare provider.

Gender

ALL

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