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
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
-
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.
-
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.
-
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.