Management options for Otitis Media with Effusion (OME) in children with Down syndrome

Chief investigator

Dr Heather Fortnum (Retired)

Study team

A Marshall

Andrew Marshall
Dr Elizabeth Marder
Claire Benton (Nottingham University Hospitals NHS Trust)
Dr Murray Smith
Dr Paul Leighton (University of Nottingham)
Kate Sutton (Nottingham Community Health)

Funder

NIHR Health Technology Assessment programme

Study period

2012

Children with Down syndrome are more likely than children without Down syndrome to suffer from glue ear, which is a build-up of non-infected sticky fluid in their ear on the far side of the ear drum. This leads to hearing difficulties, which can lead to problems with language and communication. There is not much evidence to help hearing specialists to decide the best way to treat this condition in children with Down syndrome. Grommets (small tubes put in the ear drum to drain the fluid) are often very difficult to insert in children with Down syndrome because they have small ears. An alternative treatment is hearing aids (HAs) but the children often will not wear them. It would be helpful to do research to find what the best treatment is.

The best research would be a trial of different treatments, with children randomly assigned to each, to see which is better. It is not clear whether or not parents and health-care professionals would agree to the child being given a treatment by chance and so this study aimed to ask parents and professionals for their views on future research, and also looked at whether or not the new information from such a trial would be cost-effective.

Parents and professionals had concerns about giving treatment by chance and thought that a study simply following the children after their routine treatment would be best. If research is to be carried out to address these issues it should examine insertion of grommets and giving HAs to children but should not include a ‘no treatment’ option. Any study should cost < £650,000.

The findings are published in Fortnum et al., 2014