None listed
Conditions
Brief summary
Aim(s): This project aims to examine the feasibility of establishing a state-wide screening program in WA to detect congenital CMV-related hearing loss in high-risk infants. The project does not aim to determine if early treatments are effective, this is outside of the scope of the study. Primary Objectives: 1. To determine the incidence of congenital CMV infection in those infants who fail their newborn hearing screen in WA 2. To monitor the clinical progression of these patients/participants over time and their patterns of hearing loss to be able to better understand the disease in WA Secondary objectives: 1. a) To identify and address potential barriers to early detection of cCMV (less than 21 days) in order to facilitate feasible (cost-effective, minimally invasive) diagnosis via a saliva swab b) To determine whether early diagnosis has the potential to make time-critical treatment possible (within 30 days). 2. If targeted testing is found to be feasible - to create and implement a protocol which forms a clinical pathway for targeted testing of infants at high-risk of cCMV in WA. Hypothesis: We hypothesise that timely targeted cCMV screening is both important and feasible to implement into WA Newborn Hearing Screening Guidelines.
Interventions
Targeted testing of infants for congenital cytomegalovirus (cCMV).
Infants are targeted using the newborn hearing screen result.
Infants who fail ('refer') on newborn hearing screening are at increased risk of cCMV and (their parents/guardians) will be contacted to offer enrolment in the study - and testing for cCMV.
Currently testing is not routinely offered at this time point.
All infants in the state (meeting eligibility criteria) will be offered enrolment.
cCMV testing (saliva and urine) p
Targeted testing of infants for congenital cytomegalovirus (cCMV). Infants are targeted using the newborn hearing screen result. Infants who fail ('refer') on newborn hearing screening are at increased risk of cCMV and (their parents/guardians) will be contacted to offer enrolment in the study - and testing for cCMV. Currently testing is not routinely offered at this time point. All infants in the state (meeting eligibility criteria) will be offered enrolment. cCMV testing (saliva and urine) protocols in the study are the same as those used by the pathology centre and each request form is attached to a 'standard operating procedure' (SOP) instruction sheet approved by this centre. The difference in the study is the testing time point, the methods of sampling and testing are standard. Parents/guardians of the infant attend a community or hospital pathology centre (at the most convenient location for the family) which has been supplied with the request form and SOP. The pathology centre staff take a buccal swab from the infant (1 minute to complete) and the sample is processed in the standard manner. Study doctor/nurse inform the parents of the result. If this is negative the infant is discharged from the study. If it is positive, the infant again attends a pathology centre for confirmation of this via urine testing (nappy with cotton wool or specimen jar) which a gold standard testing protocol (if wet nappy, can taken within 1 minute, if not await wet nappy - usually less than 1 hour). Study staff inform the family of the result, which if negative results in discharge from the study, if positive the usual care pathway (Audiology testing, ENT, Infectious diseases, Ophthalmology) is activated and expedited. There are no further requirements from the infant and their family besides the saliva and urine testing, apart from access to the infants medical records which are reviewed for the duration of the (2 year) study to assess their clinical outcomes, in the cases of cCMV positive infants only. The study staff assess testing attendance as every result is followed up - indicating willingness to participate. Additional investigative and treatment decision-making for cCMV positive infants is observed only.
Sponsors
Dr Jafri Kuthubutheen
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
No minimum to 14 Days
Healthy volunteers
No
Inclusion criteria
During the 2 year study 1. all infants born in Western Australia undergoing newborn hearing screening which results in a 'refer' (fail) result in one or both ears 2. Are age less than day 11 for rural/remote infants and day 14 for infants in metropolitan area on the day the 'refer' result is received by the study team 3. Has a legally acceptable representative able to provide informed consent on behalf of the infant
Exclusion criteria
1. Newborn hearing screen ‘refer’ result but infant aged over 11 days of age (rural/remote participants) and 14 days of age (metropolitan participant) 2. Medically unwell – although not specifically excluded from the study some Infants may be too unwell to reasonably take part. In consultation with the treating team, the research team would consider the appropriateness of approaching the guardians. 3. Lack of a legally acceptable representative able to provide informed consent on behalf of the infant.
Outcome results
None listed