Oral Glibenclamide in Preterm Infants With Hyperglycaemia (GALOP)
Status: Recruiting
Location: See location...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Maximum Age: 7 months
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
France
Hopital Necker - Enfants malades
RECRUITING
Paris
Contact Information
Primary
Elsa KERMORVANT, Pr
elsa.kermorvant@aphp.fr
01 71 19 61 75
Backup
Laure CHOUPEAUX, Master
laure.choupeaux@aphp.fr
01 44 38 17 11
Time Frame
Start Date: 2023-05-20
Estimated Completion Date: 2027-02-20
Participants
Target number of participants: 35
Treatments
Experimental: Glibenclamide oral
Amglidia®: glibenclamide oral suspension 6 mg/ml administered by gastric tube after dilution to 1/6th in human milk
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris