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GALOP : Oral glibenclamide in hyperglycaemia of the premature infant
EU CTIS ID: 2024-512230-15-00
What this study is testing
To assess the 72-hour efficacy of an enteral suspension of glibenclamide in controlling transient hyperglycaemia in premature infants weighing less than 1500 g.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - Newborn less than 34 weeks post-mentrual age
- - Birth weight < 1500 g
- - Gestational age < 32 weeks
- - Hyperglycaemia ≥ 10 mmol/l on 2 measurements taken at least 3 hours apart after eventual reduction of glucose intakes following each unit’s protocol (if not consecutive, within a maximum interval of 9 hours)
- - Secure venous access point (umbilical venous catheter or epicutaneo-cava catheter)
- - Enteral feeding considered or already started prior to enrolment
You likely can't join if
- - Contraindication to enteral feeding (at the discretion of the clinician responsible for the child)
- - Profound hypophosphoremia (< 1 mmol/l)
- - RCIU PN < 3ème perc. (définition Audipog)
- - Hypersensitivity to glibenclamide or other sulphonylureas or sulphonamides, or one of the excipients
- - Patient with continuous insulin IV administration
- - Patient treated with miconazole
See the full eligibility criteria
- - Newborn less than 34 weeks post-mentrual age
- - Birth weight < 1500 g
- - Gestational age < 32 weeks
- - Hyperglycaemia ≥ 10 mmol/l on 2 measurements taken at least 3 hours apart after eventual reduction of glucose intakes following each unit’s protocol (if not consecutive, within a maximum interval of 9 hours)
- - Secure venous access point (umbilical venous catheter or epicutaneo-cava catheter)
- - Enteral feeding considered or already started prior to enrolment
- - Consent obtained from legal guardians
- - Beneficiary of social security
- - Contraindication to enteral feeding (at the discretion of the clinician responsible for the child)
- - Profound hypophosphoremia (< 1 mmol/l)
- - RCIU PN < 3ème perc. (définition Audipog)
- - Hypersensitivity to glibenclamide or other sulphonylureas or sulphonamides, or one of the excipients
- - Patient with continuous insulin IV administration
- - Patient treated with miconazole
- - 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 (if assessment indicated: V factor less than the standard laboratory range for the age) and/or severe cholestasis (conjugated bilirubin > 50 µmol/L)
- - Hyperglycaemia associated with an error in administering glucose infusion
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.