Oral steroids for otitis media with effusion in children study

• Research type

  Research Study

• Full title

  Oral steroids for the resolution of otitis media with effusion in children study (OSTRICH)

• IRAS ID

  119358

• Contact name

  francisna

• Sponsor organisation

  Cardiff University, Research and Commercial Division

• Eudract number

  2012-005123-32

• ISRCTN Number

  ISRCTN49798431

• Research summary

  Otitis media with effusion (OME), also known as glue ear, is an accumulation of fluid in the middle ear. While OME usually gets better by itself, for thousands of children every year it can result in deafness, which can affect speech and social development. If deafness lasts longer than 3 months, children are usually offered hearing aids or a grommet operation (insertion of ventilation tubes through the eardrum of tympanic membrane). Both of these have risks, are costly, and require repeated hospital visits. Finding a simple, safe, effective treatment would be of great benefit to children, their families and the NHS. There is evidence from pooling findings from small trials that a short course of oral steroids may work for OME. However, these trials were either too small, of too short duration, or of poor quality. There is uncertainty about meaningful, longer-term benefit. OSTRICH is a double-blinded, randomised controlled trial aiming to determine if a 7 day course of oral steroids improves the hearing of children with OME in the short and longer term. A short course of oral steroids is frequently used for acute asthma in young children, and is considered safe.We aim to recruit 380 children aged 2-8 years who are seen in hospital Ear, Nose and Throat departments in Wales, with symptoms attributable to OME for at least 3 months and confirmed bilateral hearing loss. Participants will be randomised to take a course of oral steroid, or a matched placebo, for one week. Measurements will be made before the start of treatment and at 5 weeks, 6 and 12 months after the day of randomisation. The main outcome will be satisfactory hearing at 5 weeks after randomisation. Other outcomes include long term satisfactory hearing, clearing of OME, children??s symptoms, quality of life, resource use and cost effectiveness.

• REC name

  Wales REC 3

• REC reference

  13/WA/0004

• Date of REC Opinion

  28 Feb 2013

• REC opinion

  Further Information Favourable Opinion