Randomised prospective study of treatment methods for middle ear effusions in pre-school children

ISRCTN ISRCTN57358603
DOI https://doi.org/10.1186/ISRCTN57358603
Secondary identifying numbers C/COM/16-08-93/MAW/F
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
22/02/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr A Maw
Scientific

United Bristol Healthcare Trust
St Michael's Hospital
St Michael's Hill
Bristol
BS2 8EG
United Kingdom

Phone +44 (0)117 921 5411
Email armaw@doctors.org.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Scientific title
Study objectivesTo determine whether immediate intervention with grommet insertion is as effective as watchful waiting in children with glue ear.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedOtitis media
Intervention1. Early treatment with ventilation tubes (grommets)
2. Watchful waiting for a period of nine months with analysis by intention to treat
Intervention typeOther
Primary outcome measureEarly surgery significantly reduced behavioural difficulty by 17% and the difference was largely mediated by concurrent hearing loss.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/04/1994
Completion date30/09/1997

Eligibility

Participant type(s)Patient
Age groupChild
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/04/1994
Date of final enrolment30/09/1997

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

United Bristol Healthcare Trust
Bristol
BS2 8EG
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive South West (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 20/03/1999 Yes No
Results article results 01/06/2000 Yes No
Results article follow up results 01/02/2009 Yes No