An observational study in Hearing Loss and Cytomegalovirus, sponsored by Newcastle-upon-Tyne Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged Up to 21 Days. Per ClinicalTrials.gov, last updated 2015-10-12.
Sponsored by Newcastle-upon-Tyne Hospitals NHS Trust · Observational
This study will look at the feasibility and acceptability of testing newborn babies who are referred after their newborn hearing screen for an infection called congenital Cytomegalovirus (cCMV). Around 1 in every 100 to 200 babies is born with this virus, and although most remain well it causes 1 in 5 cases of childhood deafness. Knowing that a baby is infected shortly after birth could have significant benefit since a treatment is now available, but screening programs need to be feasible and acceptable. This study aims to evaluate targeted screening for cCMV by taking samples (saliva and urine) from babies who do not pass their newborn hearing screening. The investigators want to see if we can find a quick, reliable and parentally acceptable way to screen babies who fail their hearing test for this virus.
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's enrollment of 411 is above the median of 87 across 270 observational studies indexed under Hearing Loss.
Browse Hearing Loss studies →Newcastle-upon-Tyne Hospitals NHS Trust is the lead sponsor of 65 studies on the registry; 4 are open to participants now.
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This population this study examines is infants in Newcastle and South West London who are referred for more hearing tests after their neonatal hearing screen.
This cohort of patients will be offered screening tests for congenital CMV infection.
Exclusion Criteria:
Babies referred for further hearing tests after their neonatal hearing screening tests
Other: Screening urine and saliva tests for congenital Cytomegalovirus
With consent for the study babies who are referred for further hearing tests will have a urine and saliva sample sent to be analysed for CMV infection
Feasibility of targeted screening for congenital CMV
Feasibility: as determined by proportion of urine and salivary swabs processed with a result back to parents and health professionals that would allow treatment if needed to be initiated by 28 days of age.
Time frame: 30 months
Acceptability of extended screening tests
Parental acceptability as determined by anxiety measures (in comparison to published data in parents whose infants are referred for failing their hearing screen, but where no mention of extended screening is made) and parental responses to extended questionnaires about the ease of the process of obtaining samples.
Time frame: 30 months
Clinical utility of extended screening tests
Secondary outcomes. Assess and compare the clinical utility of performing salivary and urine CMV testing on babies referred through NHSP in terms of: 1. rate of diagnosis of cCMV by day 21 2. rate of initiation of treatment, where clinically indicated, by 4 weeks of age. 2. Calculate the prevalence of cCMV in children with SNHL detected following newborn hearing screening (number per population screened)
Time frame: 30 months
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Newcastle-upon-Tyne Hospitals NHS Trust