Oral steroids for resolution of otitis media with effusion in children
| ISRCTN | ISRCTN49798431 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49798431 |
| EudraCT/CTIS number | 2012-005123-32 |
| Secondary identifying numbers | HTA 11/01/26; SPON1030-11 |
- Submission date
- 06/12/2012
- Registration date
- 07/12/2012
- Last edited
- 09/11/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Plain English Summary
Background and study aims:
Otitis media, also known as glue ear, is a common condition, especially in young children. Whilst we know that glue ear often gets better by itself, thousands of children each year experience prolonged hearing loss, which can lead to further problems. If hearing loss lasts longer than 3 months, children are usually offered hearing aids or a grommet operation. Several small research studies have suggested that treatment with oral steroids might help glue ear get better quicker. Oral steroids reduce inflammation in the body and are often used to treat conditions like asthma. However, the research done so far is not as good as we would like it to be, so we still cant say for definite whether a child with glue ear will benefit from treatment (e.g. improved hearing, glue ear gets better, no longer needs an operation for grommets) with an oral steroid. We want to answer these questions by testing the use of oral steroids (prednisolone sodium phosphate) in a research study being run from Cardiff University.
Who can participate?
Children aged between 2 to 8 years who have been referred to an Ear, Nose and Throat (ENT) outpatient clinic with symptoms of hearing loss due to glue ear for at least 3 months.
What does the study involve?
The study involves visiting the ENT clinic for a hearing assessment and taking home a short course of oral steroids to be given to the child once a day for 7 days, by dissolving it in liquid. We also ask parents to complete a diary recording their childs symptoms and any additional healthcare consultations their child has had over the subsequent 5 weeks. There will be follow up assessments at the ENT clinic at 5 weeks, 6 and 12 months.
What are the possible benefits and risks of participating?
A possible benefit of this study is that there may be a possibility that if the treatment works, the childs hearing will improve so that they will no longer need hearing aids or grommet surgery. In addition, the child will also have extra assessments and monitoring in the ENT clinic, which may be helpful. Participants in this study will be helping us answer questions about the treatment of glue ear in children that should result in better care for children with this condition in the future. Taking part in the study will mean giving up some time. There is a chance that the child might develop side effects from the study treatment. However, side effects are uncommon with these treatments (especially when only taken for short periods of time), and are not usually serious.
Where is the study run from?
University Hospital of Wales (lead site) and nineteen hospitals in England and Wales (UK)
When is the study starting and how long is it expected to run for?
September 2013 to April 2017
Who is funding the study?
National Institute for Health Research - Health Technology Assessment Programme (UK)
Who is the main contact?
Dr Cherry-Ann Waldron
Waldronc@cardiff.ac.uk
Contact information
Scientific
Cardiff University
Institute of Primary Care and Public Health
School of Medicine
5th Floor, Neuadd Meirionnydd
Heath Park
Cardiff
CF14 4YS
United Kingdom
Study information
| Study design | Randomised double-blind placebo-controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | http://www.ostrich-study.co.uk/parents.php |
| Scientific title | A randomised double blind placebo controlled clinical trial using oral steroids for the resolution of otitis media with effusion (OME) in children |
| Study acronym | OSTRICH |
| Study hypothesis | To determine the clinical and cost effectiveness of a 7-day course of oral prednisolone (steroid) on improving hearing loss over the short term in children with bilateral OME, as diagnosed at an ENT outpatient clinic, who have had symptoms attributable to OME present for at least 3 months, and current significant hearing loss (demonstrated by audiometry). |
| Ethics approval(s) | Wales Research Ethics Committee, 13/01/2013 ref: 13/WA/0004 |
| Condition | Otitis Media with Effusion (OME) or glue ear |
| Intervention | A 7-day course of oral soluble Prednisolone, as a single daily dose of 20mg for children aged 2-5 years or 30mg for 6-8 year olds and a matched placebo in the control group. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Prednisolone |
| Primary outcome measure | Acceptable hearing at five weeks from randomisation (four weeks after conclusion of treatment), where acceptable hearing is defined as less than 20 dB averaged at 0.5, 1, 2 and 4 kHz in at least one ear in children aged 3-8 years, and less than 25 dB averaged at 0.5, 1, 2 and 4 KHz by sound field VRA in children aged under 3 years. These thresholds are based on national guidelines. |
| Secondary outcome measures | Current secondary outcome measures as of 17/12/2012: 1. Satisfactory hearing at 6 and 12 months, measured as above, 2. Tympanometry (using calibrated standardised tympanometers and modified Jeger classification Types B and C2) 3. Otoscopic findings 4. Healthcare consultations related to OME, and other resource use 5. Grommet surgery at 6, and 12 months 6. Adverse effects 7. Symptoms (reported by parent and/or child) 8. Functional health status (OM8-30) 9. Health related quality of life (PedsQL and HUI3) 10. Short and longer term cost effectiveness Previous secondary outcome measures until 17/12/2012: 1. Satisfactory hearing at 3, 6, and 12 months, measured as above, 2. Tympanometry (using calibrated standardised tympanometers and modified Jeger classification Types B and C2) 3. Otoscopic findings 4. Healthcare consultations related to OME, and other resource use 5. Grommet surgery at 3, 6, and 12 months 6. Adverse effects 7. Symptoms (reported by parent and/or child) 8. Functional health status (OM8-30) 9. Health related quality of life (PedsQL and HUI3) 10. Short and longer term cost effectiveness |
| Overall study start date | 01/03/2013 |
| Overall study end date | 27/04/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 8 Years |
| Sex | Both |
| Target number of participants | 380 |
| Participant inclusion criteria | Updated 11/06/2015: 1. Aged 2-8 years (reached 2nd birthday and not yet reached 9th birthday) 2. Had symptoms of hearing loss attributable to OME for at least 3 months (or had audiometry proven hearing loss for at least 3 months) 3. Diagnosis of bilateral OME made in an ENT clinic on the day of recruitment or during the preceding week 4. Audiometry confirming hearing loss of more than 20 dBHL averaged within the frequencies of 0.5, 1, 2, and 4 KHz in both ears by pure tone audiometry ear specific insert visual reinforcement audiometry (VRA) or ear specific play audiometry, or hearing loss of more than 25 dBHL averaged within the frequencies of 0.5, 1, 2, and 4 KHz by soundfield VRA or soundfield performance/play audiometry in the better hearing ear, on the day of recruitment or within the preceding 14 days 5. First time in the OSTRICH trial 6. Ability of parent/carer to understand and give informed consent Updated 19/06/2013: 1. Aged 2-8 years (reached 2nd birthday and not yet reached 9th birthday) 2. Had symptoms of hearing loss attributable to OME for at least 3 months (or had audiometry proven hearing loss for at least 3 months) 3. Diagnosis of bilateral OME made in an ENT clinic on the day of recruitment or during the preceding week 4. Audiometry confirming hearing loss of more than 20 dBHL averaged within the frequencies of 0.5, 1, 2, and 4 KHz in both ears by pure tone audiometry ear specific insert visual reinforcement audiometry (VRA) or ear specific play audiometry, or hearing loss of more than 25 dBHL averaged within the frequencies of 0.5, 1, 2, and 4 KHz by soundfield VRA or soundfield performance/play audiometry in the better hearing ear, on the day of recruitment or in the preceding week 5. First time in the OSTRICH trial 6. Ability of parent/carer to understand and give informed consent 7. Does not already have grommets (ventilation tubes) Original inclusion criteria: 1. Aged 2-8 years (reached 2nd birthday and not yet reached 9th birthday), 2. Had symptoms of hearing loss attributable to OME for at least 3 months (or had audiometry proven hearing loss for at least 3 months), 3. Diagnosis of bilateral OME made in an ENT clinic on the day of recruitment or during the preceding week, 4. Audiometry confirming hearing loss of more than 20 dB averaged at 0.5, 1, 2, and 4 KHz in the better ear by pure tone audiometry in children 3 years of age or more or hearing loss of more than 25 dB averaged over 0.5, 1, 2, and 4 KHz by sound field visual reinforcement audiometry (VRA) in children less than 3 years of age, on the day of recruitment or in the preceding week. |
| Participant exclusion criteria | Updated 28/09/2015: 1. Children who are currently involved in another CTIMP or have participated in a CTIMP during the last 4 months 2. Children with current systemic infection or ear infection 3. Children with cleft palate 4. Children with Down’s syndrome 5. Children with diabetes mellitus 6. Children with Kartagener’s or Primary Ciliary Dyskinesia 7. Children with renal failure, hypertension or congestive heart failure 8. Children with confirmed, major developmental difficulties (e.g. are tube fed, have chromosomal abnormalities) 9. Children who have taken oral steroids in the preceding four weeks 10. Children who have had a live vaccine in the preceding four weeks if aged under 3 years old (not yet reached 3rd birthday) 11. Children with a condition that increases their risk of adverse effects from oral steroids (i.e. on treatment likely to modify the immune system or who are immunocompromised, such as undergoing cancer treatment) 12. Children who have been in close contact with someone known or suspected to have Varicella (chicken pox) or active Zoster (Shingles) during the three weeks prior to recruitment and have no prior history of Varicella infection or immunisation 13. Children with existing known sensory hearing loss 14. Children who already have grommets (ventilation tubes) 15. Children who are on a waiting list for grommet surgery and anticipate having surgery within 5 weeks and are unwilling to delay it Updated 11/06/2015: 1. Children who are currently involved in another CTIMP or have participated in a CTIMP during the last 4 months 2. Children with current systemic infection or ear infection 3. Children with cleft palate 4. Children with Down’s syndrome 5. Children with diabetes mellitus 6. Children with Kartagener’s or Primary Ciliary Dyskinesia 7. Children with renal failure, hypertension or congestive heart failure 8. Children with confirmed, major developmental difficulties (e.g. are tube fed, have chromosomal abnormalities) 9. Children who have taken oral steroids in the preceding four weeks 10. Children who have had a live vaccine in the preceding four weeks 11. Children with a condition that increases their risk of adverse effects from oral steroids (i.e. on treatment likely to modify the immune system or who are immunocompromised, such as undergoing cancer treatment) 12. Children who have been in close contact with someone known or suspected to have Varicella (chicken pox) or active Zoster (Shingles) during the three weeks prior to recruitment and have no prior history of Varicella infection or immunisation 13. Children with existing known sensory hearing loss 14. Children who already have grommets (ventilation tubes) 15. Children who are on a waiting list for grommet surgery and anticipate having surgery within 5 weeks and are unwilling to delay it Updated 19/06/2013: 1. Children who are currently involved in another CTIMP or have participated in a CTIMP during the last 4 months 2. Children with current systemic infection or ear infection 3. Children with cleft palate 4. Children with Down’s syndrome 5. Children with diabetes mellitus 6. Children with Kartagener’s or Primary Ciliary Dyskinesia 7. Children with renal failure, hypertension or congestive heart failure 8. Children with confirmed, major developmental difficulties (e.g. are tube fed, have chromosomal abnormalities) 9. Children who have taken oral steroids in the preceding four weeks 10. Children with a condition that increases their risk of adverse effects from oral steroids (i.e. on treatment likely to modify the immune system or who are immunocompromised, such as undergoing cancer treatment) 11. Children who have been in close contact with someone known or suspected to have Varicella (chicken pox) or active Zoster (Shingles) during the three weeks prior to recruitment and have no prior history of Varicella infection or immunisation 12. Children with existing known sensory hearing loss 13. Children who are on a waiting list for grommet surgery and anticipate having surgery within 5 weeks and are unwilling to delay it Updated 17/12/2012: 1. Children with cleft palate 2. Children with Downs syndrome 3. Children with confirmed, major developmental difficulties (e.g. are tube fed, have chromosomal abnormalities) 4. Children with current systemic infection 5. Children with renal failure, hypertension or congestive heart failure 6. Children with diabetes mellitus 7. Children who have taken oral steroids in the preceding four weeks 8. Children with a condition that increases their risk of adverse effects from oral steroids (i.e. on treatment likely to modify the immune system or who are immunocompromised) 9. Children with no prior history of Varicella (Chicken Pox) infection or immunisation and who have been in close contact with someone known or suspected to have Varicella or active Zoster (Shingles) during the three weeks prior to recruitment 10. Children who are currently involved in another CTIMP or have participated in a CTIMP during the last 4 months Original exclusion criteria: 1. Children with cleft palate 2. Children with Downs syndrome 3. Children with confirmed, major developmental difficulties (e.g. are tube fed, have chromosomal abnormalities) 4. Children who have taken oral steroids in the preceding four weeks 5. Children with a condition that increases their risk of adverse effects from oral steroids (i.e. on treatment likely to modify the immune system or who are immunocompromised including insulin dependent diabetes mellitus) 6. Children with no prior history of Varicella (Chicken Pox) infection or immunisation and who have been in close contact with someone known or suspected to have Varicella or active Zoster (Shingles) during the three weeks prior to recruitment |
| Recruitment start date | 18/03/2014 |
| Recruitment end date | 31/03/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
Cardiff
CF14 4XW
United Kingdom
Pontyclun
CF72 8XR
United Kingdom
Carmarthen
SA31 2AF
United Kingdom
Newport
NP20 2UB
United Kingdom
Sketty
Swansea
SA2 8QA
United Kingdom
Bridgend
CF31 1RQ
United Kingdom
Wrexham
LL13 7TD
United Kingdom
Wolverhampton
WV11 3PG
United Kingdom
Bradford
BD9 6RJ
United Kingdom
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Maidstone
ME16 9QQ
United Kingdom
Tunbridge Wells
TN2 4QJ
United Kingdom
Harrow
HA1 3UJ
United Kingdom
London
WC1X 8DA
United Kingdom
Stoke-on-Trent
ST4 6QG
United Kingdom
Newport
Isle of Wight
PO30 5TG
United Kingdom
Redhill
RH1 5RH
United Kingdom
Blackpool
FY3 8NR
United Kingdom
Walsall
WS2 9PS
United Kingdom
Worcester
WR5 1DD
United Kingdom
Sponsor information
University/education
Research and Commercial Division
7th Floor
30-36 Newport Road
Cardiff
CF24 0DE
Wales
United Kingdom
| Website | http:www.cardiff.ac.uk |
|---|---|
"ROR" |
https://ror.org/03kk7td41 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Nick Francis (FrancisNA@cardiff.ac.uk). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/03/2016 | Yes | No | |
| Results article | results | 18/08/2018 | Yes | No | |
| Basic results | 23/08/2018 | 23/08/2018 | No | No | |
| Results article | results | 01/11/2018 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN49798431_BasicResults_23Aug18.pdf
- Uploaded 23/08/2018
Editorial Notes
09/11/2018: Publication reference added.
29/08/2018: Publication reference added.
23/08/2018: The basic results of this trial have been uploaded as an additional file
24/04/2017: The overall trial end date was changed from 01/09/2017 to 27/04/2017.
09/09/2016: The publication and dissemination plan, availability of participant level data and trial participating centres have been added.
08/09/2016: The overall trial dates have been updated from 01/09/2013 - 01/09/2015 to 01/03/2013 - 01/09/2017 and the recruitment dates have been updated from 01/09/2013 - 01/09/2015 to 18/03/2014 - 31/03/2016.
02/03/2016: Publication reference added.
