Reference: 2011-023 - Surgery for the Treatment of Otitis Media in Indigenous Children

Researchers: Prof Stephen O’Leary (Royal Victorian Eye & Ear Hospital); Prof Harvey Coates (PMH for Children); A/Prof Kelvin Kong (Newcastle); A/Prof Peter Morris (Royal Darwin Hospital); A/Prof Chris Perry (Royal Children’s Hospital Brisbane); Ms Adrienne Kirby (University of Sydney

Funding: NHMRC

Project summary: Ear infection (otitis media) is a major problem amongst children living in remote Australian communities. Medical treatment often fails, and ear nose and throat surgeons are called upon to provide surgical care. This clinical trial will provide surgeons with evidence so that they can recommend the best possible operation for children living in desert and tropical regions, most of whom are indigenous, to improve hearing and reduce the prevalence of ear infection and discharging ears.

This will be a multi-centre randomised trial across remote areas of NT & WA. It will assess the effects of two surgical interventions in the management of otitis media. Aboriginal and Torres Strait Islander children, between the ages of 3-10 years will be randomized into 3 groups:

  1. adenoidectomy with ventilation tubes (VTA)

  2. adenoidectomy with myringotomy only (MA)

  3. medical treatment with the offer of surgery after 12 months if clinically indicated.

The children will be followed up for 12 months following surgery. This will be by monthly phone calls to the family to ask about the child’s ear health and a visit to the community after 12 months to test hearing and review ear and nasal swabs. It is expected that by the end of this period the ventilation tube will have dropped out (usually after 3-6 months), and that the otitis media will likely have recurred if were to do so.

The primary aim is to see a reduction in the prevalence of otitis media. Secondary aims include measuring hearing impairment, the prevalence of aural discharge, aural perforation, and the effect of treatment on nasal colonisation with pathogenic bacteria. The study will test whether there is an advantage of VTA or MA over medical therapy in controlling otitis media.

Progress: Ongoing