Randomised prospective study of treatment methods for middle ear effusions in pre-school children
| ISRCTN | ISRCTN57358603 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57358603 |
| Protocol serial number | C/COM/16-08-93/MAW/F |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive South West (UK) |
- 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
Scientific
United Bristol Healthcare Trust
St Michael's Hospital
St Michael's Hill
Bristol
BS2 8EG
United Kingdom
| Phone | +44 (0)117 921 5411 |
|---|---|
| armaw@doctors.org.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To 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) studied | 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 |
| Primary outcome measure(s) |
Early surgery significantly reduced behavioural difficulty by 17% and the difference was largely mediated by concurrent hearing loss. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/09/1997 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Key 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 |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/04/1994 |
| Date of final enrolment | 30/09/1997 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
United Bristol Healthcare Trust
Bristol
BS2 8EG
United Kingdom
BS2 8EG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
