Condition category
Ear, Nose and Throat
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
22/02/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr A Maw

ORCID ID

Contact details

United Bristol Healthcare Trust
St Michael's Hospital
St Michael's Hill
Bristol
BS2 8EG
United Kingdom
+44 (0)117 921 5411
armaw@doctors.org.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

C/COM/16-08-93/MAW/F

Study information

Scientific title

Acronym

Study hypothesis

To determine whether immediate intervention with grommet insertion is as effective as watchful waiting in children with glue ear.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Otitis media

Intervention

1. Early treatment with ventilation tubes (grommets)
2. Watchful waiting for a period of nine months with analysis by intention to treat

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Early surgery significantly reduced behavioural difficulty by 17% and the difference was largely mediated by concurrent hearing loss.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/1994

Overall trial end date

30/09/1997

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/04/1994

Recruitment end date

30/09/1997

Locations

Countries of recruitment

United Kingdom

Trial participating centre

United Bristol Healthcare Trust
Bristol
BS2 8EG
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive South West (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Results

    Wilks J, Maw R, Peters TJ, Harvey I, Golding J, Randomised controlled trial of early surgery versus watchful waiting for glue ear: the effect on behavioural problems in pre-school children., Clin Otolaryngol Allied Sci, 2000, 25, 3, 209-214.

  2. Follow up results

    Hall AJ, Maw AR, Steer CD, Developmental outcomes in early compared with delayed surgery for glue ear up to age 7 years: a randomised controlled trial., Clin Otolaryngol, 2009, 34, 1, 12-20, doi: 10.1111/j.1749-4486.2008.01838.x.

  3. Maw R, Wilks J, Harvey I, Peters TJ, Golding J, Early surgery compared with watchful waiting for glue ear and effect on language development in preschool children: a randomised trial., Lancet, 1999, 353, 9157, 960-963, doi: 10.1016/S0140-6736(98)05295-7.

Additional files

Editorial Notes