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| [ Print-friendly version ] |
| Oral steroids for resolution of otitis media with effusion in children |
| ISRCTN | ISRCTN49798431 |
| DOI | 10.1186/ISRCTN49798431 |
| ClinicalTrials.gov identifier | |
| EudraCT number | 2012-005123-32 |
| Public title | Oral steroids for resolution of otitis media with effusion in children |
| Scientific title | A randomised double blind placebo controlled clinical trial using oral steroids for the resolution of otitis media with effusion (OME) in children |
| Acronym | OSTRICH |
| Serial number at source | SPON1030-11 |
| 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).
More details can be found here: http://www.hta.ac.uk/project/2896.asp |
| Lay 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 can’t 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 child’s 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 child’s 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? Cardiff University, UK When is the study starting and how long is it expected to run for? The study will be It will be starting in September 2013 and run until September 2015. 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 |
| Ethics approval | Wales Research Ethics Committee, 13 January 2013 ref: 13/WA/0004 |
| Study design | Randomised double blind placebo controlled clinical trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Otitis Media with Effusion (OME) or glue ear. |
| Participants - 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. |
| Participants - exclusion criteria |
Current exclusion criteria as of 17/12/2012:
1. Children with cleft palate, 2. Children with Down’s 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. Previous exclusion criteria until 17/12/2012: 1. Children with cleft palate 2. Children with Down’s 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 |
| Anticipated start date | 01/09/2013 |
| Anticipated end date | 01/09/2015 |
| Status of trial | Ongoing |
| Patient information material | http://www.ostrich-study.co.uk (will be added shortly) |
| Target number of participants | 380 |
| Interventions | 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. |
| Primary outcome measure(s) | 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 measure(s) |
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 |
| Sources of funding | NIHR Health Technology Assessment - HTA (UK) ref: 11/01/26 |
| Trial website | http://www.ostrich-study.co.uk |
| Publications | |
| Contact name | Dr Nick Francis |
| Address |
Cardiff University
Institute of Primary Care and Public Health School of Medicine 5th Floor, Neuadd Meirionnydd Heath Park |
| City/town | Cardiff |
| Zip/Postcode | CF14 4YS |
| Country | United Kingdom |
| Sponsor | Cardiff University (UK) |
| Address |
Research and Commercial Division
7th Floor 30-36 Newport Road |
| City/town | Cardiff |
| Zip/Postcode | CF24 0DE |
| Country | United Kingdom |
| Sponsor website: | http:www.cardiff.ac.uk |
| Date applied | 06/12/2012 |
| Last edited | 17/12/2012 |
| Date ISRCTN assigned | 07/12/2012 |
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