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

Newcastle-upon-Tyne Hospitals NHS Trust

Status: Completed

Conditions: Cytomegalovirus; Hearing Loss

Treatments: Other: Screening urine and saliva tests for congenital Cytomegalovirus

Study type: Observational

Funder types: Other

Identifiers

NCT01162330

10/H0904/25 (Other Identifier)

5286

Details and patient eligibility

About

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.

Enrollment: 411 patients

Sex: All

Ages: Under 21 days old

Volunteers: No Healthy Volunteers

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.

Trial design

411 participants in 1 patient group

Babies referred for further hearing tests

Description:

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

Treatment:

Other: Screening urine and saliva tests for congenital Cytomegalovirus