NCT01162330|Completed
The Benefits Feasibility and Acceptability of Extended Screening Testing in Newborn Babies Who Are Referred for Further Hearing Assessment
BEST
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BEST
Sponsor study identifier
Secondary identifiers
OTHER · REC
observational
411
1 country
1
Study Start
August 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2013
Actual (reported)Study Completion
February 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 13, 2010
Actual (reported)July 14, 2010
Actual (reported)August 2010
Date type not reportedThis date has not been verified as actual or estimated.
February 2013
Actual (reported)February 2013
Actual (reported)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
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
Clinical utility of extended screening tests
30 months
Babies referred for further hearing tests after their neonatal hearing screening tests
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Royal Victoria Infirmary, Newcastle Hospital NHS Trust
Newcastle upon Tyne, Tyne and Wear, NE1 4LP, United Kingdom
Julia Clark
Newcastle-upon-Tyne Hospitals NHS Trust
Janet Berrington
Newcastle-upon-Tyne Hospitals NHS Trust
Mike Sharland
St Georges Healthcare Trust
Suzanne Luck
Royal Free Hospital NHS Foundation Trust
411 participants (actual enrollment reported by the registry).
First Submitted
July 13, 2010
First Posted
July 14, 2010
Study Start
August 2010
Date type not reportedThis date has not been verified as actual or estimated.
Observation of Benefits for Patients Implanted With a Hearing Implant of the Company Cochlear
Contact the study team to confirm eligibility.
Primary Completion
February 2013
Actual (reported)Study Completion
February 2013
Actual (reported)Last Updated
October 12, 2015
Record last verified: 2015-10
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Source: ClinicalTrials.gov.
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