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

Hearing Loss Clinical Trial

— BEST  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01162330
• Other study ID #: 5286
• Secondary ID: 10/H0904/25
• Status: Completed
• Phase: N/A
• First received: July 13, 2010
• Last updated: October 7, 2015
• Start date: August 2010
• Est. completion date: February 2013

Study information

• Verified date: October 2015
• Source: Newcastle-upon-Tyne Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 411
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Days

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cytomegalovirus
• Deafness
• Hearing Loss

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Royal Victoria Infirmary, Newcastle Hospital NHS Trust	Newcastle upon Tyne	Tyne and Wear

Sponsors (1)

Lead Sponsor	Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 months	No
Primary	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.	30 months	No
Secondary	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: rate of diagnosis of cCMV by day 21; 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)	30 months	No