NCT01162330

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 411 (actual)
• Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust · Academic / Other
• Sex: All
• Age: 21 Days
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hearing Loss
• Cytomegalovirus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-08-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2010-07-14
• Last updated: 2015-10-12

Locations

1 site across 1 country: United Kingdom