Title 
Oral Steroids for Resolution of Otitis Media with Effusion (OME) In CHildren: the OSTRICH study

Value
£1,083,208

Funder
NIHR HTA

Principal Investigator
Dr Nick Francis and Prof Chris Butler

Co-Investigators
Kerry Hood, Alun Tomkinson, Rebecca Cannings-John, Ceri Phillips, Colin Powell, Micaela Gal.

Type of study
RCT

Summary
Otitis media with effusion (OME, also known as glue ear) is an accumulation of fluid in the middle ear. About 80% of children have had OME by age 4.  OME often gets better by itself, but for thousands of children every year it can result in deafness, which can affect speech and social development and result in depression and attention disorders. If deafness lasts longer than 3 months, children are usually offered hearing aids or a grommet operation. Both these procedures have associated risks and side effects, are costly, and require repeated visits to hospital clinics. In the UK, 23,000 children had grommets inserted under general anaesthetic in 2009. Finding 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 the NHS. 

Many oral medications 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 these studies were either too small or of poor quality, so there is uncertainty about meaningful, longer term benefit. We propose a rigorous clinical trial to determine if a short course of oral steroids improves the hearing of children with OME in the short and long term. A short course of oral steroids is a frequently used treatment for acute asthma in young children, and is considered safe.

Link with RDG / CSG or similar
Infection, SEWTU

Start date
2012

End date
2015

Further information
www.ostrich-study.co.uk