Clinical trial NCT01162330: The Benefits Feasibility and Acceptability of Extended Screening Testing in Newborn Babies Who Are Referred for Further Hearing Assessment
Official title: The Benefits Feasibility and Acceptability of Extended Screening Testing in Newborn Babies Who Are Referred for Further Hearing Assessment After Their Neonatal Screen (BEST)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss
Cytomegalovirus
Keywords: Screening
Congenital Cytomegalovirus
CMV
Hearing loss
Lead sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2010-07-14
Enrollment: 411
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of targeted screening for congenital CMV
timeFrame: 30 months
measure: Acceptability of extended screening tests
timeFrame: 30 months
Secondary outcomes:
measure: Clinical utility of extended screening tests
timeFrame: 30 months
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary, Newcastle Hospital NHS Trust
state: Tyne and Wear
Study officials:
affiliation: Newcastle-upon-Tyne Hospitals NHS Trust
name: Julia Clark
role: STUDY_CHAIR
affiliation: Newcastle-upon-Tyne Hospitals NHS Trust
name: Janet Berrington
role: PRINCIPAL_INVESTIGATOR
affiliation: St Georges Healthcare Trust
name: Mike Sharland
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Free Hospital NHS Foundation Trust
name: Suzanne Luck
role: PRINCIPAL_INVESTIGATOR
References: