CMV diagnostics for newborns with hearing loss

     

In many cases CMV hearing loss is progressive and gets worse over time. Gancyclovir treatment may be able to prevent a baby's hearing loss from getting worse. However it must be started before a baby is 1 month old and very few babies are currently diagnosed with CMV this early. 

A series of studies in the UK have been investigating rapid diagnostics to test babies who fail their newborn hearing screen for CMV.  This would enable more babies to benefit from antiviral treatment.  Results so far are positive

BEST 1 – (The Benefits, feasibility and acceptability of Extended Screening Testing in newborn babies who are referred for further hearing assessment after their neonatal screen)

What was the purpose of the study?

To examine the feasibility, acceptability and effectiveness of screening for cCMV infection in newborn infants who are referred following universal newborn hearing screening and specifically compare:

  • The additional parental anxiety generated by raising the possibility of CMV infection over and above that of ‘failing’ the hearing screen.
  • How easy it is to get urine or saliva specimens and which one parents prefer.
  • The ability to complete cCMV screening, return a result to the family and GP and commence treatment of cCMV if needed by 28 days of life.

How did researchers go about testing this?

In total, 411 participants were recruited from Newcastle and south west London between August 2010 - October 2012. Parents of newborns who did not pass their initial newborn hearing test were approached by screeners to be contacted by the study team. Study packs were sent to parents’ homes which contained consent forms, anxiety questionnaires, saliva and urine swabs.  Parents were asked to collect saliva or urine samples themselves at home and post them back to the researchers along with completed questionnaires

What is the status of the study? Complete

What were the results?

  • Over 98% of samples were processed within the first 3 weeks of life.
  • Six newborns were found to have congenital CMV (3 with hearing loss and all 3 were treated with valganciclovir within the first month of life).
  • There was no difference in anxiety levels between parents of babies who had a saliva swab taken to test for CMV compared to controls.
  • 97% (217/223) of parents who responded to the questionnaires stated that they thought screening for cCMV using a saliva swab in babies who were referred after their initial hearing screen was a good idea.
  • The major limitation in the study was that only 40% of all eligible recruits took part due to research procedures including inherent problems with postal recruitment.
  • In September 2011, of the completed parental questionnaires returned, 97% (76/78) felt that salivary swabs were easier to collect than urine and 96% (72/75) indicated their preference for saliva over urine collection. The study team deemed that urine collection was not a practical screening method and recommended that saliva swabs only be collected.

 

Where can I find out more?

Full details are in the clinical trials register

An academic paper reporting the results was published in the Archives of Disease in Childhood

 

BEST 2: (The Benefits, feasibility and acceptability of Extended Screening Testing in newborn babies who are referred for further hearing assessment after their neonatal screen)

 

What is the purpose of the study?

This next stage was to run a study that would be closer to a ‘real life’ model with saliva swabs for CMV testing taken by newborn hearing screeners, not researchers  The objective was to assess whether it is feasible to integrate testing for cCMV into the newborn hearing screening programme by enabling hearing screeners to take saliva samples at the point of referring a baby for further hearing tests. 

How did researchers go about testing this?

By training newborn hearing screeners in South West London to take saliva swabs, rather than posting out packs to parents at home.  Researchers tracked the number of babies referred for additional hearing screening who successfully had a saliva swab taken and asked the hearing screeners for their views.

What is the status of the study? Complete

When were the results? The BEST 2 study showed that this model is feasible.  Newborn hearing screeners felt confident doing the tests and they were able to test nearly 80% of babies referred for further hearing assessment

     

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