GALOP: Oral Glibenclamide in premature hyperglycemia

Conditions

Transient hyperglycaemia in premature infants

Brief summary

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)

Detailed description

• 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

Related papers

No related papers found yet.

Interventions

DRUGAMGLIDIA 6 mg/mL oral suspension

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
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)	—

Secondary

Measure	Time frame
• 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	—

Measure

Time frame

• 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

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Countries

France

Outcome results

None listed