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ISRCTN
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ISRCTN56018683
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ClinicalTrials.gov identifier
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Public title
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The effects of aluminium exposure in the neonatal period on brain, cognition and bone health in children born preterm
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0012146854
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Study hypothesis
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This study sets out to investigate whether aluminium toxicity due to contaminate of intravenous feeding solutions cause long lasting adverse effects on brain, cognition and bone health.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Neonatal Diseases: feeding
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Participants - inclusion criteria
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Children born prematurely and require intravenous feeding
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/2004
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Anticipated end date
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31/12/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Participants: 80
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Interventions
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1. Standard feeding solution
2. Specially constituted feeding solution
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Great Ormond Street Hospital for Children NHS Trust / Institute of Child Health (UK)
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Trial website
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Publications
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2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19858156
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Contact name
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Dr
CJ
Edmonds
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Address
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c/o Research & Development Office
Great Ormond Street Hospital
Great Ormond Street
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City/town
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London
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Zip/Postcode
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WC1N 3JH
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Country
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United Kingdom
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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19/04/2011
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Date ISRCTN assigned
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30/09/2005
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