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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janet Berrington, Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT01162330
First received: July 13, 2010
Last updated: December 7, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Hearing Loss
Cytomegalovirus
 Other: Screening urine and saliva tests for congenital Cytomegalovirus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Newcastle-upon-Tyne Hospitals NHS Trust:

Primary Outcome Measures:
  • Feasibility of targeted screening for congenital CMV [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    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.

  • Acceptability of extended screening tests [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Clinical utility of extended screening tests [ Time Frame: 30 months ] [ Designated as safety issue: No ]

    Secondary outcomes.

    Assess and compare the clinical utility of performing salivary and urine CMV testing on babies referred through NHSP in terms of:

    1. rate of diagnosis of cCMV by day 21
    2. 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)


Estimated Enrollment: 428
Study Start Date: August 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Babies referred for further hearing tests
Babies referred for further hearing tests after their neonatal hearing screening tests
 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

  Eligibility

Ages Eligible for Study:   up to 21 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01162330

Locations
United Kingdom
Royal Victoria Infirmary, Newcastle Hospital NHS Trust
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 4LP
Sponsors and Collaborators
Janet Berrington
Investigators
Study Chair: Julia Clark Newcastle Hospitals NHS trust
Principal Investigator: Janet Berrington Newcastle Hospitals NHS trust
Principal Investigator: Mike Sharland St Georges Healthcare Trust
Principal Investigator: Suzanne Luck Royal Free Hospital
  More Information

No publications provided

Responsible Party: Janet Berrington, Neonatal consultant, Northumbria PI, Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT01162330     History of Changes
Other Study ID Numbers: 5286, 10/H0904/25
Study First Received: July 13, 2010
Last Updated: December 7, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Newcastle-upon-Tyne Hospitals NHS Trust:
Screening
Congenital Cytomegalovirus
CMV
Hearing loss

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013