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Completed
NCT05687500
Oral Glibenclamide in Preterm Infants With Hyperglycaemia (GALOP)
Conditions: Transient; Hypoglycemia, Neonatal, Preterm, Glibenclamide Adverse Reaction
Sex: All
Ages: N/A – 34 Weeks
Healthy volunteers: No
Phase: PHASE2
Enrollment: 35
Sponsor: Assistance Publique - Hôpitaux de Paris
Location: Hopital Necker - Enfants malades Paris
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.
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
Source: ClinicalTrials.gov (NCT05687500). StuddyBuddy aggregates publicly available trial information.