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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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11 September 2023 |
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Main ID: |
NCT03530189 |
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Date of registration:
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22/04/2018 |
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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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Outcome of Very Preterm Infants With Glucose Level Disturbances
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Scientific title:
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Neurodevelopmental Outcome of Very Preterm Infants With Glucose Level Disturbances at the Age of Two |
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Date of first enrolment:
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January 1, 2018 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03530189 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Croatia
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Contacts
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Name:
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Ivona Butorac Ahel, MD, MS |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Center Rijeka, 51 000 Rijeka, Croatia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- infants born weighing <1500 g or at <32 weeks of gestation
Exclusion Criteria:
- infants with significant congenital abnormalities
- infants died before day 7
- infants whose mothers suffer from type 1, type 2 diabetes mellitus or gestational
diabetes
Age minimum:
24 Weeks
Age maximum:
27 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cerebral Palsy Infantile
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Intervention(s)
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Drug: 10% dextrose
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Drug: bolus of dextrose, reducing the glucose infusion, insulin
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Primary Outcome(s)
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Neurodevelopmental outcome of each group at the age of two performed using Bayley Scales of Infant and Toddler Development Bayley III
[Time Frame: up to 27 months]
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Secondary ID(s)
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istrazivanje01
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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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