Hearing LossBESTNCT01162330
The Benefits Feasibility and Acceptability of Extended Screening Testing in Newborn Babies Who Are Referred for Further Hearing Assessment
An observational study of Hearing Loss and Cytomegalovirus, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 21 days
- Conditions the study is for
- Hearing Loss, Cytomegalovirus
- What is being tested?
- Screening urine and saliva tests for congenital Cytomegalovirus
- How many people
- 411 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2010to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 days
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Victoria Infirmary, Newcastle Hospital NHS Trust
Newcastle upon Tyne, Tyne and Wear, NE1 4LP
About this study
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)
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
- Being tested
- Screening urine and saliva tests for congenital Cytomegalovirus
- Keywords
- Screening, Congenital Cytomegalovirus, CMV, Hearing loss
- Medical subject headings
- Hearing Loss, Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening urine and saliva tests for congenital CytomegalovirusOther
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
| Study group | Role | What they receive |
|---|---|---|
| Babies referred for further hearing tests | Babies referred for further hearing tests after their neonatal hearing screening tests Receives: Other: Screening urine and saliva tests for congenital Cytomegalovirus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 months
Secondary outcomes (1)
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)
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia Clark, Study chair, Newcastle-upon-Tyne Hospitals NHS TrustJanet Berrington, Principal investigator, Newcastle-upon-Tyne Hospitals NHS TrustMike Sharland, Principal investigator, St Georges Healthcare TrustSuzanne Luck, Principal investigator, Royal Free Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162330
- Sponsor's protocol ID
- 5286
- Other IDs
- 10/H0904/25
- Acronym
- BEST
- Status last verified
- Oct 2015
- First submitted
- 13 Jul 2010
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01162330
- Acronym / sponsor ID
- BEST / 5286
- Conditions
- Hearing Loss, Cytomegalovirus
- Keywords
- Screening, Congenital Cytomegalovirus, CMV, Hearing loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- Newcastle-upon-Tyne Hospitals NHS TrustUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 14 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Babies referred for further hearing tests | – | Other: Screening urine and saliva tests for congenital CytomegalovirusBabies referred for further hearing tests after their neonatal hearing screening tests |
Who may qualify
- Ages
- Up to 21 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening urine and saliva tests for congenital CytomegalovirusWith 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 | Other | Babies referred for further hearing tests |
Primary outcome
Feasibility of targeted screening for congenital CMV
Time frame: 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
Time frame: 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.
1 secondary outcome
Clinical utility of extended screening tests
Time frame: 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Clark study chair
Newcastle-upon-Tyne Hospitals NHS Trust
Janet Berrington principal investigator
Newcastle-upon-Tyne Hospitals NHS Trust
Mike Sharland principal investigator
St Georges Healthcare Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss and Cytomegalovirus, run by Newcastle-upon-Tyne Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of targeted screening for congenital CMV (time frame: 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2015.