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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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19 February 2015 |
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Main ID: |
NCT00217191 |
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Date of registration:
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14/09/2005 |
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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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Ibuprofen and Renal Function in Premature Infants
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Scientific title:
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Ibuprofen and Renal Function in Premature Infants |
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Date of first enrolment:
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September 2004 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00217191 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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France
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Contacts
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Name:
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Jean-Michel HASCOET, 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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University of Nancy, France |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Gestational Age = 27 to 31 weeks
- Postnatal age < 48 hours
- Parental Consent Obtained
Exclusion Criteria:
- Renal malformation
- Urinary tract infection
- Renal Failure
- Pulmonary Hypertension at echocardiography
Age minimum:
N/A
Age maximum:
28 Days
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Premature Infants
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Patent Ductus Arteriosus
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Intervention(s)
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Drug: Ibuprofen
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Primary Outcome(s)
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Creatinine Clearance on day seven postnatally
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Secondary Outcome(s)
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Rate and severity of Intraventricular Hemorrhage
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Renal function maturation over 28 days
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Rate of necrotizing enterocolitis
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Rate of ductus closure after treatment
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Mortality
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Secondary ID(s)
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MRAP040833
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PHRC2004:17-06
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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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