Oral Steroids for the resolution of otitis media with effusion in children study
Otitis media with effusion (OME, also known as glue ear) is an accumulation of usually sticky fluid in the middle ear. About 80% of children have had OME by the age of 4 years. For most, OME gets better by itself. But for thousands of children each year it results in deafness that could affect speech and social development, their learning, and result in depression, behavioural and attention disorders.
If deafness lasts longer than 3 months, children are usually offered hearing aids or a grommet operation (suction of the sticky fluid out of the middle ear and insertion of a ventilation tube through the ear drum to maintain a normal pressure). Both have risks and side effects, are costly, and require repeated visits to hospital clinics. The number of grommet operations performed in England and Wales has fallen primarily because of advice to follow a three-month ‘watchful waiting’ strategy before proceeding to surgery. However, OME remains the commonest reason for childhood surgery (>25 000 operations each year in the UK) and represents a considerable opportunity cost for the NHS. A simple, safe, acceptable, effective treatment that can also be used in children in the first four years of life in general practice would be of great benefit to children, their families and allow more care to be provided cost effectively in the community.
Many oral medications, including antibiotics, antihistamines and decongestants, do not work for OME. However, there is evidence from pooling findings from small trials that a short course of oral steroids may work, but trials conducted so far have been either too small, of poor quality, or have not assessed hearing as an outcome, so there is uncertainty about whether there are meaningful short and longer term benefits. There are good scientific grounds for believing that steroids might be beneficial for this condition and there is evidence from laboratory studies that they are helpful.
This randomised clinical trial aims to determine if a short course of oral steroids improves the hearing of children with OME in the short and longer term.
A short course of oral steroids is a frequently used treatment for acute asthma in young children, and there is good safety evidence.
A trained research nurse will seek informed consent from parents of children aged 2 – 8 years who are seen in a hospital ENT department with symptoms attributable to OME for at least 3 months and have confirmed bilateral hearing loss. Participants will take a course of oral steroid, or a matched placebo, for one week. Measurements, including hearing, persistence of glue ear, functional health status and quality of life, will be made just before the start of treatment and at 5 weeks, 6 and 12 months.
The main outcome will be satisfactory hearing (in at least one ear in children 3 years and over and using both ears in 2 year olds) 4 weeks after steroid treatment (five weeks after randomisation). Other outcomes will include satisfactory hearing in the long term, clearing of OME, children’s symptoms as recorded in a diary, adverse events, functional health status, quality of life, resource use and cost, and cost effectiveness.
We propose a 3 year study with a 6 month set-up period, 12 months to recruit participants, 12 months follow-up, and 6 months for data cleaning, analysis, and report writing. We plan on recruiting 380 participants through 6 hospital sites. We have already had provisional agreement from these sites. This sample will be large enough to determine whether oral steroids produce a meaningful improvement in hearing and thus an important reduction in grommet operations.
Dr Emma Thomas-Jones – Senior Trial Manager
Dr Cherry-Ann Waldron – Trial Manager
Ms Rebecca Cannings-John – Trial Statistician
Prof Kerry Hood
Dr Micaela Gal
Prof Ceri Philips – Professor of Health Economics, Swansea University
Mr Alun Tomkinson (Consultant ENT surgeon, UHW)
Dr Amanda Roberts – Associate Specialist Community Paediatrics
Dr Colin Powell – Senior Lecturer in Child Health
Dr Mathew Smith – Clinical Pharmacist
Mrs Judith Evans – Research Administrator