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ISRCTN
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ISRCTN57358603
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ClinicalTrials.gov identifier
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Public title
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Randomised prospective study of treatment methods for middle ear effusions in pre-school children
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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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C/COM/16-08-93/MAW/F
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Study hypothesis
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To determine whether immediate intervention with grommet insertion is as effective as watchful waiting in children with glue ear.
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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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Otitis media
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Participants - inclusion criteria
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1. Children born between April 1, 1991, and Dec 31, 1992,
2. Confirmed bilateral otitis media with effusion (OME)
3. Bilateral hearing impairment of 25-70 dB of at least 3 months' duration
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Participants - exclusion criteria
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Does not meet inclusion criteria
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Anticipated start date
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01/04/1994
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Anticipated end date
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30/09/1997
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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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Not provided at time of registration
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Interventions
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1. Early treatment with ventilation tubes (grommets)
2. Watchful waiting for a period of nine months with analysis by intention to treat
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Primary outcome measure(s)
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Early surgery significantly reduced behavioural difficulty by 17% and the difference was largely mediated by concurrent hearing loss.
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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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NHS Executive South West (UK)
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Trial website
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Publications
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1. 1999 results in http://www.ncbi.nlm.nih.gov/pubmed/10459904
2. 2000 results in http://www.ncbi.nlm.nih.gov/pubmed/10944051
2. 2009 follow up results in http://www.ncbi.nlm.nih.gov/pubmed/19260880
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Contact name
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Mr
A
Maw
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Address
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United Bristol Healthcare Trust
St Michael's Hospital
St Michael's Hill
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City/town
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Bristol
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Zip/Postcode
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BS2 8EG
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Country
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United Kingdom
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Tel
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+44 (0)117 921 5411
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Email
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armaw@doctors.org.uk
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Sponsor
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NHS R&D Regional Programme Register - 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.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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22/02/2010
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Date ISRCTN assigned
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23/01/2004
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