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

Completed

• Conditions: Hearing Loss; Cytomegalovirus
• Interventions: Other: Screening urine and saliva tests for congenital Cytomegalovirus

• Registration Number: NCT01162330
• Lead Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-13
• Study First Submitted QC: 2010-07-13
• Study First Posted: 2010-07-14
• Study Start: 2010-08
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-07
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 411

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Babies referred for further hearing tests	Screening urine and saliva tests for congenital Cytomegalovirus	Babies referred for further hearing tests after their neonatal hearing screening tests

Primary Outcome Measures

Name	Time	Method
Feasibility of targeted screening for congenital CMV	30 months	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	30 months	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

Name	Time	Method
Clinical utility of extended screening tests	30 months	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)

Trial Locations

Locations (1)

Royal Victoria Infirmary, Newcastle Hospital NHS Trust; 🇬🇧 Newcastle upon Tyne, Tyne and Wear, United Kingdom