Oral STeroids for the Resolution of otitis media with effusion (OME) In CHildren.
Otitis media with effusion (OME), also known as glue ear, is a common condition, especially in young children. Whilst glue ear usually gets better by itself, in thousands of children each year it can cause hearing loss, which can lead to further problems such as difficulty with learning and speech development. If hearing loss lasts longer than 3 months, children are often offered hearing aids or a grommet operation.
Some studies have found that taking a prescribed steroid medication for a short period seems to result in glue ear getting better in some children. However, the studies that have been done so far have been small, have mostly not measured the effect on hearing, and have not measured how long any effects last. This provides good rationale for a rigorous randomised controlled trial to end the debate and determine if a short course of oral steroids improves the hearing of children with OME in the short and longer term.
We planned to recruit 380 participants (children aged 2-8 years) from hospitals in Wales and England. Participants take a course of oral steroid, or a matched placebo, for one week. Measurements include hearing, persistence of glue ear, functional health status and quality of life. These measurements are taken before the start of treatment and at 5 weeks, 6 and 12 months. The main outcome assessed is satisfactory hearing 4 weeks after treatment. Other outcomes include satisfactory hearing in the longer term, clearing of OME, quality of life, and cost effectiveness.
Public and patient involvement
Public and patient representatives on our steering and management committees have provided us with valuable input throughout the duration of the trial from the design stage, questionnaire development and recruitment. One representative appeared on the BBC Wales news and was interviewed on BBC Wales breakfast radio to help provide exposure to the trial and give her experiences of having a child with glue ear. This generated a lot of interest from parents who wanted their children to take part in the trial.
Potential impact of study
Recruitment has just completed, with some participants undergoing follow ups until March 2017. The potential research impact of this study is that if treatment with an oral steroid does improve hearing, then it is likely that some children can avoid needing an operation or having to wear a hearing aid.
Professor Chris Butler at the University of Oxford, who co-led the study with Professor Nick Francis at Cardiff University, said:
"Glue ear is an important cause of deafness and the most common reason for children to have an operation in the UK. If oral steroids, which are commonly used as a treatment for asthma in children, prove to be effective, we will be able to offer parents a new treatment choice to improve their child's quality of life and that may avert the need for an operation. Such an approach is also likely to result in significant savings for the NHS."
|Start date||6 Dec 2012|
|End date||1 Sep 2017|