Targeted Screening for Congenital Cytomegalovirus-related Hearing loss in infants in Western Australia
Perth Childrens HospitalDataset description
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.Date Information
Source Study
Purpose:
Phase:
Trial acronym
Not available
Trial ID
ACTRN12621000484842
Funding
Charities/Societies/Foundations, the Garnett-Passe Foundation
Scientific enquiries
Dr Allison Reid
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 o .... Read more
Key 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
Key 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 i .... Read more
Can healthy volunteers participate?
No
Population
Sample Size 204
Min. age No limit
Max. age 14 Days
Sex Both males and females
Condition category Congenital CMV-related Hearing Loss
Condition code Ear , Infection
Intervention
Intervention code Early detection / Screening
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) pro .... Read more
Comparison
Control group Uncontrolled
No control
Outcomes
Outcome: To assess whether targeted congenital cytomegalovirus testing is able to be completed by day 21 of life in Infants at high-risk of the virus across Western Australia Used to assess this: The proportion of infants unable to be recruited due to delayed NBHS testing/delayed communication of these results/unable to contact the parents or guardians by day 14 of life/infants who do not attend testing centres despite being enrolled The electronic hospital results platform is .... Read more