Trial · NCT05687500
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Blood glucose control | 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) |
| Secondary | Overall success of the treatment | At 36 week of amenorrhea corrected age | Overall success of the treatment defined by continuation to the end of treatment without recourse to insulin. |
| Secondary | Blood glucose profile on glibenclamide | At the end of treatment assessed up to 15 days | Time between the start of glibenclamide treatment and the 1st blood glucose \< 10 mmol/l |
| Secondary | Blood glucose profile on glibenclamide | At the end of treatment assessed up to 15 days | Time between the start of glibenclamide treatment and the 1st blood glucose \< 8 mmol/l |
| Secondary | Blood glucose profile on glibenclamide | At the end of treatment assessed up to 15 days | Proportion of time spent within the target blood glucose range (≥ 4 and \< 10 mmol/l) during the period of glibenclamide treatment |
| Secondary | Blood glucose profile on glibenclamide | At the end of treatment assessed up to 15 days | Proportion of time spent above the target level (≥ 10 mmol/l) during the period of glibenclamide treatment |
| Secondary | Blood glucose profile on glibenclamide | At the end of treatment assessed up to 15 days | Proportion of time spent in hypoglycemia (\< 2.6 mmol/l) during the period of glibenclamide treatment |
| Secondary | Duration of glibenclamide treatment | At the end of treatment assessed up to 15 days | Duration of glibenclamide treatment. |
| Secondary | Nutritional intakes and growth | At the end of treatment assessed up to 15 days | Carbohydrate |
| Secondary | Nutritional intakes and growth: | At the end of treatment assessed up to 15 days | lipid |
| Secondary | Nutritional intakes and growth: | At the end of treatment assessed up to 15 days | protein |
| Secondary | Nutritional intakes and growth: | At the end of treatment assessed up to 15 days | mean caloric intake (kcal/kg/day) during treatment |
| Secondary | Nutritional intakes and growth: | At the end of treatment assessed up to 15 days | mean weight gain (g/kg/day) |
| Secondary | Nutritional intakes and growth | At 36 week of amenorrhea corrected age | Carbohydrate |
| Secondary | Nutritional intakes and growth: | At 36 week of amenorrhea corrected age | lipid |
| Secondary | Nutritional intakes and growth: | At 36 week of amenorrhea corrected age | protein |
| Secondary | Nutritional intakes and growth: | At 36 week of amenorrhea corrected age | mean caloric intake (kcal/kg/day) during treatment |
| Secondary | Nutritional intakes and growth: | At 36 week of amenorrhea corrected age | mean weight gain ((g/kg/day) |
| Secondary | Number of children with episode of hypoglycemia | At 72 hours after first administration | Number of children with at least one episode of moderate (blood glucose \< 2.6 mmol/l) or severe (\< 1.5 mmol/l) hypoglycemia |
| Secondary | Number of children with episode of hypoglycemia | At the end of treatment assessed up to 15 days | Number of children with at least one episode of moderate (blood glucose \< 2.6 mmol/l) or severe (\< 1.5 mmol/l) hypoglycemia |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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