Oral Glibenclamide in Preterm Infants With Hyperglycaemia (GALOP)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Blood glucose control
研究概览
简要总结
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.
详细描述
Transient hyperglycemia of premature newborns results from an overall decrease in insulin sensitivity, which is responsible at the beta cell level for abnormalities of intragranular cleavage of proinsulin into insulin, leading to reduced active insulin secretion. Intravenous administration of exogenous insulin can be used to combat insulin resistance and lower blood glucose, but it is difficult to manage in premature newborns and is associated with a substantial risk of hypoglycemia. Glibenclamide, which stimulates endogenous insulin secretion and can be administered orally, might be an alternative to insulin therapy in treating transient hyperglycemia of premature newborns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 34 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Glibenclamide oral
Amglidia®: glibenclamide oral suspension 6 mg/ml administered by gastric tube after dilution to 1/6th in human milk
干预措施: Glibenclamide (Drug)
Glibenclamide oral
Amglidia®: glibenclamide oral suspension 6 mg/ml administered by gastric tube after dilution to 1/6th in human milk
干预措施: Pharmacokinetics study (Biological)
Glibenclamide oral
Amglidia®: glibenclamide oral suspension 6 mg/ml administered by gastric tube after dilution to 1/6th in human milk
干预措施: Routine biological monitoring (Biological)
Glibenclamide oral
Amglidia®: glibenclamide oral suspension 6 mg/ml administered by gastric tube after dilution to 1/6th in human milk
干预措施: C-peptide proinsulin ratio (Biological)
结局指标
主要结局
Blood glucose control
时间窗: At 72 hours after the first administration
The primary evaluation criteria is 72 hours blood glucose control on glibenclamide treatment (success of the treatment). This is defined as the non-use of insulin and absence of severe hypoglycemia (\< 1.5 mmol/l) or persistent moderate hypoglycemia (\< 2.6 mmol/l in 2 successive measurements (dextro) at an interval of more than 3 hours)
次要结局
- Overall success of the treatment(At 36 week of amenorrhea corrected age)
- Duration of glibenclamide treatment(At the end of treatment assessed up to 15 days)
- Nutritional intakes and growth(At 36 week of amenorrhea corrected age)
- Number of adverse reactions on glibenclamide(At 36 week of amenorrhea corrected age)
- Number of children with episode of hypoglycemia(At the end of treatment assessed up to 15 days)
- Type of adverse reactions on glibenclamide(At 36 week of amenorrhea corrected age)
- Number of participants with co-morbidity(At 36 week of amenorrhea corrected age)
- Dose adjustment(At the end of treatment assessed up to 15 days)
- ease of use by caregivers(At day three of treatment)
- Plasma concentrations of glibenclamide(At 24 hours of blood glucose stabilization)
- Mortality(At 36 week of amenorrhea corrected age)
- Nutritional intakes and growth(At the end of treatment assessed up to 15 days)
- Blood glucose profile on glibenclamide(At the end of treatment assessed up to 15 days)
- Nutritional intakes and growth:(At 36 week of amenorrhea corrected age)
- Nutritional intakes and growth:(At the end of treatment assessed up to 15 days)
- Number of children with episode of hypoglycemia(At 72 hours after first administration)
- ease of use by caregivers(At day one of treatment)
- ease of use by caregivers(At day two of treatment)
- Plasma concentrations of glibenclamide(At 3 hours after the first administration)
- Plasma concentrations of glibenclamide(At 6 hours after the first administration)
- Plasma concentrations of glibenclamide(At 10 hours after the first administration)
- Plasma concentrations of glibenclamide(At 24 hours after the first administration)