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| ID | Type | Description | Link |
|---|---|---|---|
| 10/H0904/25 | Other Identifier | REC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Babies referred for further hearing tests | Babies referred for further hearing tests after their neonatal hearing screening tests |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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:
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Victoria Infirmary, Newcastle Hospital NHS Trust | Newcastle upon Tyne | Tyne and Wear | NE1 4LP | United Kingdom |
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| 30 months |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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