The Benefits Feasibility and Acceptability of Extended Screening Testing in Newborn Babies Who Are Referred for Further Hearing Assessment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

411 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Hearing Loss Cytomegalovirus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Babies referred for further hearing tests

Babies referred for further hearing tests after their neonatal hearing screening tests

Screening urine and saliva tests for congenital Cytomegalovirus

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All infants 'referred' for one or both ears following hospital-based newborn hearing screening in North of Tyne and South West London areas. Babies with other known causes of SNHL (e.g. hereditary) and those admitted to Neonatal Intensive Care Units will be included.

Exclusion Criteria

* Exclusions to this study will be infants with parents/guardians not willing/able to give informed consent or children known to have congenital CMV by antenatal testing or clinical features of CMV infection at birth.

Maximum Eligible Age

21 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No