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ISRCTN
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ISRCTN89169926
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ClinicalTrials.gov identifier
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Public title
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Extending Midwife/nurse Roles in the routine Examination of the Newborn: randomised controlled evaluation and cost-effectiveness (EMREN trial)
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Scientific title
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Acronym
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EMREN
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Serial number at source
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HTA 94/40/05
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Study hypothesis
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The project will evaluate the cost effectiveness of extending midwifery practice in the routine examination of the newborn. The main study is an RCT, with 1000 babies in each arm, of outcome and cost effectiveness of examination by trained junior doctors compared with examination by trained midwives. The value of a further examination at ten days will also be assessed. In depth interviews will be held with paediatricians, midwives, GPs, nurses, patients and Royal Colleges. Effects on the NHS labour market and training needs will be analysed. The research addressed general and specific issues of extending nursing and midwifery roles, concerns regarding junior doctor hours and the timing of examinations of newborn babies, and will inform NHS policy.
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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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Pregnancy and childbirth: Childbirth
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Participants - inclusion criteria
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Newborn infants
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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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01/03/1999
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Anticipated end date
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31/08/2001
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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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2000
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Interventions
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1. Neonatal examination by trained junior doctors
2. Neonatal examination by trained mid-wives
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Primary outcome measure(s)
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Referrals assessed as appropriate and as major or minor by three independent consultants. Problems identified during the first year of life assessed as identifiable at 24 hours. Quality assessment by video against an agreed written proforma. Maternal satisfaction. Opinion of professionals and mothers about aspects of the examination.
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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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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15038906
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Contact name
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Prof
Joy
Townsend
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Address
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The Public & Environmental Health Research Unit (PEHRU)
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 7485 6591/927 2185
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Fax
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+44 (0)20 7637 3238
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Email
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joy.townsend@lshtm.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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25/01/2008
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Date ISRCTN assigned
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25/04/2003
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