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

NCT01162330 | Completed

• 2 other identifiers: 528610/H0904/25
• Study Type: observational
• Target: 411
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss; Cytomegalovirus

Keywords

Screening; Congenital Cytomegalovirus; CMV; Hearing loss

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Clinical utility of extended screening tests

  30 months

Study Arms (1)

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

Interventions

Screening urine and saliva tests for congenital Cytomegalovirus OTHER

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

Babies referred for further hearing tests

Eligibility Criteria

• Age: Up to 21 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Newcastle-upon-Tyne Hospitals NHS Trust: lead

Study Sites (1)

Royal Victoria Infirmary, Newcastle Hospital NHS Trust

Newcastle upon Tyne, Tyne and Wear, NE1 4LP, United Kingdom

Location

MeSH Terms

Conditions

Hearing Loss; Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Julia Clark

  Newcastle-upon-Tyne Hospitals NHS Trust

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2010
• First Posted: July 14, 2010
• Study Start: August 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: October 12, 2015

Record last verified: 2015-10

Locations

GB (1)