Using Glibenclamide to Treat High Blood Sugar in Premature Infants
Oral Glibenclamide in Preterm Infants with Hyperglycaemia (GALOP)
This study is testing if a medication called Glibenclamide can help premature infants with high blood sugar instead of using insulin.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | N/A to 34 Weeks |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05687500 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of oral Glibenclamide as an alternative to insulin therapy for treating transient hyperglycemia in premature newborns. It focuses on infants born before 34 weeks of gestation and weighing less than 1500 grams, who exhibit high blood sugar levels. The study will monitor the pharmacokinetics of Glibenclamide and its impact on blood glucose levels, while ensuring routine biological monitoring to assess safety and efficacy.
Who should consider this trial
Good fit: Ideal candidates for this study are newborns less than 34 weeks of gestation with a birth weight under 1500 grams who are experiencing transient hyperglycemia.
Not a fit: Patients with severe birth defects, significant growth restrictions, or contraindications to enteral feeding or Glibenclamide will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more manageable treatment option for high blood sugar in premature infants.
How similar studies have performed: While the use of Glibenclamide in this context is novel, previous studies have explored its efficacy in other populations, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- Hopital Necker - Enfants malades — Paris, France (Recruiting)
Study contacts
- Study coordinator: Elsa KERMORVANT, Pr
- Email: elsa.kermorvant@aphp.fr
- Phone: 01 71 19 61 75
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.