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

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

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss; Cytomegalovirus
• Intervention / Treatment: Other: Screening urine and saliva tests for congenital Cytomegalovirus

• Study Type: Observational
• Enrollment (Actual): 411

Contacts and Locations

Study Locations

• United Kingdom
  • Tyne and Wear
    • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 4LP
      • Royal Victoria Infirmary, Newcastle Hospital NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
• Investigators: Study Chair: Julia Clark, Newcastle-upon-Tyne Hospitals NHS Trust; Principal Investigator: Janet Berrington, Newcastle-upon-Tyne Hospitals NHS Trust; Principal Investigator: Mike Sharland, St Georges Healthcare Trust; Principal Investigator: Suzanne Luck, Royal Free Hospital NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: July 13, 2010
• First Submitted That Met QC Criteria: July 13, 2010
• First Posted (Estimate): July 14, 2010

Study Record Updates

• Last Update Posted (Estimate): October 12, 2015
• Last Update Submitted That Met QC Criteria: October 7, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Screening; CMV; Hearing loss; Congenital Cytomegalovirus
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: 5286; 10/H0904/25 (Other Identifier: REC)