Australian Clinical Trials

Broad Health Condition Ear
Infection

Specific Health ConditionDeafness
Other infectious diseases

Trial FocusDiagnosis

Recruitment Details

Recruitment status
Recruiting

Recruitment State
WA

Hospital
Perth Children's Hospital - Nedlands

Anticipated date of last participant enrolment7/11/2022

Phase of TrialNot Applicable

Has the study received ethics approval?Approved

Trial 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.

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

GenderBoth males and females

Can Healthy volunteers participate? No

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 infant.