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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT01099462 |
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Date of registration:
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06/04/2010 |
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Primary sponsor: |
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Public title:
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Ibuprofen Concentration in Cerebro Spinal Fluid (CSF) of Infants and Children
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Scientific title:
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Date of first enrolment:
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June 2007 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01099462 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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Israel
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Contacts
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Name:
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Eran Kozer, MD |
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Address:
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Telephone:
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97289779916 |
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Email:
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erank@asaf.health.gov.il |
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Affiliation:
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Name:
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Eran Kozer, MD |
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Address:
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Telephone:
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97289779916 |
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Email:
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erank@asaf.health.gov.il |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age: 3 month-18 years
- Rectal temperature > 38.0OC or oral temperature > 37.6 OC measured in the ED or at
home.
- A sepsis work up is indicated
- At least one dose of Ibuprofen was given in the last 8 hours prior to lumbar puncture
(LP)
Exclusion Criteria:
- Hypersensitivity to Ibuprofen
- Known metabolic disorder
- Known liver or kidney disease
- Hydrocephalus
- Informed consent could not be obtained from a legal guardian
Age minimum:
3 Months
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Fever
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Intervention(s)
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Drug: Ibuprofen
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Primary Outcome(s)
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Ibuprofen concentration in the CSF
[Time Frame: 30 - 360 minutes after administration]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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