A study protocol for a cluster randomised trial for the prevention of chronic suppurative otitis media in children in Jumla, Nepal.

Background: Chronic Suppurative Otitis Media (CSOM) is the commonest cause of preventable deafness, affecting 164 million people worldwide, 90 % of whom live in low resource countries, such as Nepal. Simple, inexpensive treatment of acute otitis media can prevent the development of CSOM and its sequelae: deafness, abscess, encephalitis, and, rarely, death. CSOM is a disease of poverty and its social determinants: low parental education, overcrowding, poor hygiene and malnutrition. Previous studies have established economic, socio-cultural and geographic barriers to care seeking for childhood illness in the developing world and, in particular, in Nepal. The ultimate aim of this research is to improve the ear health of the children in Jumla, Nepal. The primary outcome is an increase in mother's knowledge, attitude and practice regarding ear disease in their children. The secondary outcome is a reduction in the prevalence of CSOM in their children.

Methods/design: Using 56 existing women's self-help groups, sample size, adjusting for clustering and data analysis, is set at 15 groups per arm. A baseline survey of 30 randomly selected groups will be performed, consisting of a knowledge, attitude and practice questionnaire aimed at women who participate in self-help groups, as well as examination of their children's ears. This will be followed by random allocation, stratified by geography, into 15 intervention and 15 control groups. The intervention groups will participate in three interactive educational sessions at their regular monthly meetings based on World Health Organisation Primary Ear and Hearing Resource, Basic Level. The control groups will continue their usual monthly group meetings. At 12 months, a follow-up assessment of both control and intervention groups will be performed, with a repeat women's survey and repeat ear examination of the children. Data analysis will be by intention to treat and clustering will be considered at every stage. Cluster level data will be analysed using t-test and individual level data using mixed effects linear regression and logistic regression random effects model as appropriate.

Discussion: Despite its remote location, Jumla has a vibrant network of health posts and community workers. This project uses existing, local resources and will be undertaken in a way that is consistent with the cultural understanding of the local community in Jumla and acceptable to local care-givers.

Trial registration: Australia and New Zealand Clinical Trials Register, ACTRN12614000231640.