Autoinflation for Aboriginal and Torres Strait Islander Children with OME (middle ear infection)

None listed

OME is the most common cause of hearing loss in childhood. When persistent, and particularly bilateral, the hearing loss resulting from OME has been associated with language delay, poor educational achievement and behavioural and developmental concerns. Aboriginal and Torres Strait Islander children have the highest rate of persistent, severe and complicated otitis media described in the literature. Persistent bilateral OME is the usual reason for surgical insertion of tympanostomy tubes (‘grommets’), the second most common cause of surgical admission to hospital for children in Australia. The net cost of otitis media in Australia in 2008 was estimated to be over one billion dollars. Given the high health and cost burden of OME, a simple low cost management option is urgently needed. Standard care for OME is initial observation, followed by referral for hearing assessment if bilateral OME persists at 3 months, surgical management with tympanostomy tubes (‘grommets’) and treatment for hearing impairment are considered. Unfortunately, in addition to being costly, tympanostomy tubes have lower success rates in Aboriginal children and can be associated with chronic ear discharge in up to 50% of this group, resulting in more hearing loss than prior to surgery. Long term antibiotics are another treatment option for prolonged OME, but have low efficacy and carry the significant risk of promoting antibiotic resistance. This study proposes the use of Otovent® nasal balloon autoinflation device, as a low cost, simple means of mechanically treating OME. High pressure exhaled air, forcibly opens the Eustachian tube (connecting the middle ear and the back of the nose), by blowing up a balloon through each nostril with the mouth closed. This re-introduces air into the middle ear space and allows the fluid to drain away. It has recently been recommended by the Royal Australian College of General Practitioners for use in OME, whilst results in non-Aboriginal children are inconclusive, the Otovent has never been tested in Aboriginal and Torres Strait Islander children. The INFLATE Trial will use RCT evidence to determine whether nasal balloon autoinflation increases resolution of OME in Aboriginal and Torres Strait Islander children at 1 month. The test group will use Otovent® 3 times daily as recommended by the product manufacturer. Duration of treatment in this study will be for a minimum of 1 to maximum of 3 months (if OME persists), in accordance with the current recommended treatment period, The comparator group will consist of standard care, that is, observation only, followed by referral for ENT assessment if reduced hearing or bilateral OME is detected at 3 Months.