Otitis Media with Effusion (OME) or glue ear Ear, Nose and Throat Otitis media, unspecified
Conditions
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.
Sponsors
Cardiff University (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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 mont
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed