Targeted Screening for Congenital Cytomegalovirus-related Hearing loss in infants in Western Australia

Full description

Aim(s): This project aims to examine the feasibility of establishing a state-wide screening program in WA to detect congenital CMV-related hearing loss in high-risk infants. The project does not aim to determine if early treatments are effective, this is outside of the scope of the study. Primary Objectives: 1. To determine the incidence of congenital CMV infection in those infants who fail their newborn hearing screen in WA 2. To monitor the clinical progression of these patients/participants over time and their patterns of hearing loss to be able to better understand the disease in WA Secondary objectives: 1. a) To identify and address potential barriers to early detection of cCMV (less than 21 days) in order to facilitate feasible (cost-effective, minimally invasive) diagnosis via a saliva swab b) To determine whether early diagnosis has the potential to make time-critical treatment possible (within 30 days). 2. If targeted testing is found to be feasible - to create and implement a protocol which forms a clinical pathway for targeted testing of infants at high-risk of cCMV in WA. Hypothesis: We hypothesise that timely targeted cCMV screening is both important and feasible to implement into WA Newborn Hearing Screening Guidelines.

The number of eligible participants based on the WA annual birth rate and 2% 'refer' rate would equate 700 annual NBHS 'refers'. Assuming an 80% enrolment rate we estimate that 560 referred babies per year will proceed to be swabbed. Assuming also, a conservative 2% rate of hearing loss attributable to cCMV in those who are swabbed, we expect to identify 11 cCMV patients out of approximately 560 participating referrals per year. Over the 2 year study period we would therefore expect to be able to estimate the incidence rate of congenital CMV infection in those who fail their NBHS with a margin of error of 1.7%, where the margin of error here is half of the 95% confidence interval width. The margin of error will be approximately 2% if only 600 swabs are obtained, say, for example, if recruitment was slower than expected or stopped after about 18 months. A Biostatistician has been consulted in relation to the power of the study.

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HeSANDA 1.0.0