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Oral steroids for the resolution of Otitis Media with Effusion (OME) in children (OSTRICH): study protocol for a randomised controlled trial

Oral steroids for the resolution of Otitis Media with Effusion (OME) in children (OSTRICH): study protocol for a randomised controlled trial
Oral steroids for the resolution of Otitis Media with Effusion (OME) in children (OSTRICH): study protocol for a randomised controlled trial
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. It 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 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 380 participants (children aged 2-8 years) 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 attributable to OME for at least 3 months and with confirmed bilateral hearing loss at study entry. Participants are randomised to a course of oral steroid or a matched placebo for one 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 There is an important evidence gap regarding clinical and cost effectiveness of short courses of oral steroid treatment for OME. Identifying an effective, safe, non-surgical intervention for OME in children for use in primary care would be of great benefit to children, their families and the NHS.
1745-6215
1-10
Waldron, Cherry-Ann
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Thomas-Jones, Emma
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Cannings-John, Rebecca
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Hood, Kerenza
af7cf839-ca85-4ea9-83c3-3dd31be88b32
Powell, Colin
528955fc-9d9d-4e07-9878-878b405f8e62
Roberts, Amanda
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Tomkinson, Alun
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Fitzsimmons, Deborah
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Gal, Micaela
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Harris, Debbie
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Shepherd, Victoria
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Butler, Christopher
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Francis, Nicholas
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Waldron, Cherry-Ann
74f893bb-7b67-4f67-b598-7d598cfd4085
Thomas-Jones, Emma
ea15d5ac-8232-4823-ab40-17bec0968520
Cannings-John, Rebecca
f45c9562-b1d0-4c6d-9c7c-8f27cd3e47cd
Hood, Kerenza
af7cf839-ca85-4ea9-83c3-3dd31be88b32
Powell, Colin
528955fc-9d9d-4e07-9878-878b405f8e62
Roberts, Amanda
c4a5d206-49c3-4a07-8cfd-5bccf8c93b3b
Tomkinson, Alun
4542f8cd-05d2-4ac5-9ee1-491983d1ee19
Fitzsimmons, Deborah
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Gal, Micaela
2d266726-f171-4a55-a381-29c5a2e42ec1
Harris, Debbie
60588324-3deb-4ea7-b1b0-4ff40db466db
Shepherd, Victoria
b0622fcc-79c1-4a83-8457-ec5ae3911bb3
Butler, Christopher
8bf4cace-c34a-4b65-838f-29c2be91e434
Francis, Nicholas
9b610883-605c-4fee-871d-defaa86ccf8e

Waldron, Cherry-Ann, Thomas-Jones, Emma, Cannings-John, Rebecca, Hood, Kerenza, Powell, Colin, Roberts, Amanda, Tomkinson, Alun, Fitzsimmons, Deborah, Gal, Micaela, Harris, Debbie, Shepherd, Victoria, Butler, Christopher and Francis, Nicholas (2016) Oral steroids for the resolution of Otitis Media with Effusion (OME) in children (OSTRICH): study protocol for a randomised controlled trial. Trials, 17, 1-10. (doi:10.1186/s13063-016-1236-1).

Record type: Article

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. It 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 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 380 participants (children aged 2-8 years) 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 attributable to OME for at least 3 months and with confirmed bilateral hearing loss at study entry. Participants are randomised to a course of oral steroid or a matched placebo for one 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 There is an important evidence gap regarding clinical and cost effectiveness of short courses of oral steroid treatment for OME. Identifying an effective, safe, non-surgical intervention for OME in children for use in primary care would be of great benefit to children, their families and the NHS.

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Published date: 1 March 2016

Identifiers

Local EPrints ID: 436080
URI: http://eprints.soton.ac.uk/id/eprint/436080
ISSN: 1745-6215
PURE UUID: fa9e9cfc-3150-4303-9840-4846475a25ee
ORCID for Nicholas Francis: ORCID iD orcid.org/0000-0001-8939-7312

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Date deposited: 27 Nov 2019 17:30
Last modified: 10 Dec 2019 01:20

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Contributors

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

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