ISRCTN49798431已完成未知
A randomised double blind placebo controlled clinical trial using oral steroids for the resolution of otitis media with effusion (OME) in children
Cardiff University (UK)0 个研究点目标入组 380 人开始时间: 2012年12月7日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 380
研究概览
简要总结
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26931619 2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/30152390 2018 results in: http://www.ncbi.nlm.nih.gov/pubmed/30407151
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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.
排除标准
- •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
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