Informations générales (source: ClinicalTrials.gov)
Oral Glibenclamide in Preterm Infants with Hyperglycaemia (GALOP) (GALOP)
Interventional
Phase 2
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
mai 2023
février 2027
05 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Armand Trousseau-La Roche Guyon | KERMORVANT Elsa | 18/04/2025 07:56:29 | Contacter | ||
| AP-HP - Hôpital Cochin | KERMORVANT Elsa | 18/04/2025 07:56:29 | Contacter | ||
| AP-HP - Hôpital Necker-Enfants Malades | KERMORVANT Elsa | 18/04/2025 07:56:29 | Contacter | ||
Critères
Tous
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
- 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