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ISRCTN
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ISRCTN65859742
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DOI
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10.1186/ISRCTN65859742
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Ultrasound imaging in the management of clinical neonatal hip instability - a randomised controlled trial
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Scientific title
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Acronym
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The Hip Trial
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Serial number at source
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G9312055
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Study hypothesis
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To assess the clinical effectiveness and cost effectiveness of a policy of ultrasound imaging to guide the decision about whether to initiate treatment for clinical hip instability in neonates. In particular the trial will assess whether the reduction in the use of splinting following ultrasound diagnosis is associated with an increased need for late treatment
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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 hip instability
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Participants - inclusion criteria
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Babies less than 6 weeks old with a clinical suspicion of neonatal hip instability
1. Suspicion confirmed by a second doctor
2. There is clinical uncertainty about whether the decision to initiate treatment should be guided by ultrasound examination
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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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01/12/1994
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Anticipated end date
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01/01/2001
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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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629
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Interventions
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Ultrasound imaging to guide the decision about whether to initiate treatment for clinical hip instability in neonates/control.
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Primary outcome measure(s)
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X-ray appearance between 12 and 24 months used as a measure of hip function, proportion of babies splinted; proportion of babies needing surgery; financial burden on families and the health services; pyschosocial impact on families
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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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Medical Research Council (UK) (ref: G9312055)
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Trial website
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Publications
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1. 2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12504396
2. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15613565
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Contact name
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Prof
Diana
Elbourne
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Address
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Medical Statistics Unit
London School of Hygiene and Tropical Medicine
Keppel Street
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City/town
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London
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Zip/Postcode
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WC1E 7HT
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Country
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United Kingdom
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Tel
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+44 (0)20 7927 2629
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Fax
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+44 (0)20 7637 2853
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Email
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diana.elbourne@lshtm.ac.uk
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Sponsor
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Medical Research Council (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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25/10/2000
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Last edited
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15/01/2009
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Date ISRCTN assigned
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25/10/2000
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