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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02989675 |
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Date of registration:
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05/12/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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SugarFACT - Sugar Requirements For African Children Trial
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Scientific title:
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SugarFACT - Sugar Requirements For African Children Trial |
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Date of first enrolment:
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December 2016 |
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Target sample size:
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410 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02989675 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Malawi
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Contacts
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Name:
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Queen Dube, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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College of Medicine, Malawi |
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Name:
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Josephine Langton, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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College of Medicine, Malawi |
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Name:
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Tim Baker, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Karolinska Institutet |
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Name:
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Helena Hildenwall, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Karolinska Institutet |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age between one month to 5 years (5 to 12 years for outcome measure no 3)
- Parent/carer willing and able to give consent
- Presence of one or several emergency signs (as defined in WHO pocket book of hospital
care for children)
- Obstructed or absent breathing
- Central cyanosis
- Severe respiratory distress
- Shock/impaired perfusion
- Coma/reduced consciousness
- Convulsions
- Severe dehydration
- Clinical concern that the child is in an emergency state
- Blood glucose 2.5-5.0mmol/l at arrival to the emergency department (3.0-5.0mmol/l for
severely malnourished children). For outcome measure no 4 children with <2.5 mmol/l on
arrival who then have 2.5-5.0 mmol/l on the repeat test 30 minutes later are also
included
Exclusion Criteria:
- Children with a known diagnosis of diabetes
- Refusal to participate by the child or guardians
Age minimum:
1 Month
Age maximum:
12 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Critical Illness
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Pediatric ALL
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Hypoglycemia Non Diabetics
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Emergencies
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Intervention(s)
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Drug: 10% dextrose
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Primary Outcome(s)
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In-hospital mortality in children 1 month to 5 years old
[Time Frame: Up to 12 months]
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Secondary Outcome(s)
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24 hours mortality in children 1 month to 5 years old
[Time Frame: 24 hours after admission]
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Secondary ID(s)
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P.01/16/1852
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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