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 sites380 target enrollmentDecember 7, 2012

Overview

Registry

who.int

Start Date

December 7, 2012

End Date

April 27, 2017

Last Updated

7 years ago

Study Type

Interventional

Sex

All

Sponsor

Cardiff University (UK)

•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)

•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