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Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

Oral steroids for the resolution of otitis media with effusion (OME) in children (OSTRICH): study protocol for a randomised controlled trial

Authors: Cherry-Ann Waldron, Emma Thomas-Jones, Rebecca Cannings-John, Kerenza Hood, Colin Powell, Amanda Roberts, Alun Tomkinson, Deborah Fitzsimmons, Micaela Gal, Debbie Harris, Victoria Shepherd, Christopher C Butler, Nicholas Francis

Published in: Trials | Issue 1/2016

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Abstract

Background

Otitis media with effusion (OME) is an accumulation of fluid in the middle ear affecting about 80 % of children by the age of 4 years. While OME usually resolves spontaneously, it can affect speech, behaviour and development. Children with persistent hearing loss associated with OME are usually offered hearing aids or insertion of ventilation tubes through the tympanic membrane. Oral steroids may be a safe and effective treatment for OME, which could be delivered in primary care. Treatment with oral steroids has the potential to benefit large numbers of children and reduce the burden of care on them and on health services. However, previous trials have either been too small with too short a follow-up period, or of too poor quality to give a definite answer.
The aim of the Oral Steroids for the Resolution of Otitis Media with Effusion in Children (OSTRICH) trial is to determine if a short course of oral steroids improves the hearing of children with OME in the short and longer term.

Methods/design

A total of 380 participants (children of 2 to 8 years of age) are recruited from Hospital Ear, Nose and Throat departments in Wales and England. A trained clinician seeks informed consent from parents of children with symptoms for at least 3 months that are attributable to OME and with confirmed bilateral hearing loss at study entry. Participants are randomised to a course of oral steroid or a matched placebo for 1 week. Outcomes include audiometry, tympanometry and otoscopy assessments; symptoms; adverse effects; functional health status; quality of life; resource use; and cost effectiveness. Participants are followed up at 5 weeks, and at 6 and 12 months after the day of randomisation. The primary outcome is audiometry-confirmed satisfactory hearing at 5 weeks.

Discussion

An important evidence gap exists regarding the clinical and cost effectiveness of short courses of oral steroid treatment for OME. Identifying an effective, safe, nonsurgical intervention for OME in children for use in primary care would be of great benefit to children, their families and the NHS.

Trial registration

ISRCTN: ISRCTN49798431 (Registered 7 December 2012)
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Metadata
Title
Oral steroids for the resolution of otitis media with effusion (OME) in children (OSTRICH): study protocol for a randomised controlled trial
Authors
Cherry-Ann Waldron
Emma Thomas-Jones
Rebecca Cannings-John
Kerenza Hood
Colin Powell
Amanda Roberts
Alun Tomkinson
Deborah Fitzsimmons
Micaela Gal
Debbie Harris
Victoria Shepherd
Christopher C Butler
Nicholas Francis
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1236-1

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