2024-512230-15-00招募中2 期
GALOP: Oral Glibenclamide in premature hyperglycemia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- The primary outcome is 72 hours glycaemic control on glibenclamide treatment (success of the treatment). This is defined as the non-use of insulin and absence of severe hypoglycaemia (< 1.5 mmol/l) or persistent moderate hypoglycaemia (< 2.6 mmol/l in 2 successive capillary measurements at an interval of more than 3 hours)
研究概览
简要总结
To assess the 72-hour efficacy of an enteral suspension of glibenclamide in controlling transient hyperglycaemia in premature infants weighing less than 1500 g.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The primary outcome is 72 hours glycaemic control on glibenclamide treatment (success of the treatment). This is defined as the non-use of insulin and absence of severe hypoglycaemia (< 1.5 mmol/l) or persistent moderate hypoglycaemia (< 2.6 mmol/l in 2 successive capillary measurements at an interval of more than 3 hours)
The primary outcome is 72 hours glycaemic control on glibenclamide treatment (success of the treatment). This is defined as the non-use of insulin and absence of severe hypoglycaemia (< 1.5 mmol/l) or persistent moderate hypoglycaemia (< 2.6 mmol/l in 2 successive capillary measurements at an interval of more than 3 hours)
次要结局
- • Overall success of the treatment defined by continuation to the end of treatment without insulin use.
- • Glycaemic profile under glibenclamide (see protocol)
- • Duration of glibenclamide treatment.
- • Nutritional intakes and growth (see protocol)
- • Number of children with at least one episode of moderate (blood glucose < 2.6 mmol/l) or severe (< 1.5 mmol/l) hypoglycaemia within the first 72 hours of treatment and for the duration of treatment
- • Number and type of adverse reactions to glibenclamide (see protocol)
- • Neonatal morbidity assessed at 36 weeks post-menstrual age: intraventricular haemorrhage, periventricular leukomalacia, retinopathy of premature newborns, haemodynamic disorders, necrotising enterocolitis
- • Mortality at 36 weeks post-menstrual age
- • Number of dose adjustments
- • Ease of use assessment score by caregivers
- • Plasma concentrations of glibenclamide
研究者
KERMORVANT Elsa (Coordinating investigator)
Scientific
Assistance Publique Hopitaux De Paris
研究点 (4)
Loading locations...
相似试验
进行中（未招募）
1 期
GALOP : Oral glibenclamide in hyperglycaemia of the premature infantCTIS2024-512230-15-00Assistance Publique Hopitaux De Paris45
撤回
2 期
Safety and efficacy of oral semaglutide in hyperglycaemic patients after renal transplantation2023-504159-29-00Rigshospitalet104
进行中（未招募）
1 期
ORAL GLIBENCLAMIDE IN HYPERGLYCAEMIA IN PREMATUREEUCTR2021-005766-18-FRAssistance Publique – Hôpitaux de Paris (AP-HP), par délégation : Direction de la Recherche Clinique et de l’Innovation45
已完成
3 期
A research study to look into how semaglutide, together with a lower dose of insulin glargine, compares to a higher dose of insulin glargine alone in people with type 2 diabetes (SUSTAIN OPTIMIZE)2024-510612-75-00Novo Nordisk A/S398
尚未招募
不适用
Effect of a Food Supplement on Glycemic Parameters in Patients With Impaired Glucose MetabolismNCT07263802Fondazione IRCCS Policlinico San Matteo di Pavia90