cCMVnet Study

Observational study of the management of infants with congenital CMV.

In set-up

Aim of the study

The objective of this study is to inform us how children present with cCMV, what is the utility of different diagnostic tests, which treatments are commonly prescribed, what side effects do children experience and what is the outcome of treatment. Specific questions include:

  1. What are the long term side effects of treatment with valganciclovir in infants treated for congenital CMV?
  2. What are the long term (to 6 years of age) hearing outcomes of infants who are asymptomatic (i.e. pass their new-born hearing screen and have no other abnormalities on investigation in the first month of life) at birth?

Inclusion criteria

  • Patients of either sex that have been diagnosed with cCMV infection:
  • Through confirmed detection of CMV in urine or saliva, by CMV-DNA PCR (or viral culture / Shell-vial) and/or CMV detection in blood or CSF by PCR within the first 21 days of life.
  • Children with cCMV retrospectively diagnosis by positive CMV-DNA PCR in dried blood spots (DBS), collected within 21 days of life.
  • Diagnosed by positive CMV-DNA PCR in dried umbilical cord blood or donated/stored umbilical cord blood sample.
  • Children whose parents give their informed consent to participate in the study.
  • Age less than 11 years old.

Exclusion criteria

  • Refusal to sign written informed consent of parents/ legal guardian.

The following data will be collected:

This is an observational, prospective/retrospective multicentre, cohort study of children diagnosed with cCMV. This study will contribute to a wider study also recruiting participants in Europe and other countries worldwide led by Dr Daniel Blazquez-Gamero in Madrid, Spain. No investigations or treatment will be carried out that are not part of routine clinical practice. Infants with cCMV are routinely followed up from an infectious diseases, audiology, ophthalmology and neurodevelopmental perspective until approximately 6 years of age, or longer if there are ongoing issues. Some children will be retrospectively diagnosed with cCMV in later childhood. Recruitment can be from any centre that manages these patients and has agreed to participate in the study.

No samples are taken in this data collection and analysis study.