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NCT Number: NCT05855889

Observational Study of the Management of Infants With Congenital CMV

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. 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.

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Key information

Conditions

Congenital Cmv Cytomegalovirus Infections DNA Virus Infections Herpesviridae Infections Infections Virus Diseases

Age range

Up to 10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Cytomegalovirus (CMV) is the most frequent cause of congenital infection worldwide, occurring in 0.2-2% of live births. It is also the most frequent cause of non-genetic hearing loss, and an important cause of neurodevelopmental delay. Clinical diagnosis of maternal infection during pregnancy is unreliable in most patients and laboratory diagnosis can be challenging, especially in non-primary infections. Screening of congenital CMV infection (cCMV) in newborns is not recommended in most countries and only targeted screening is performed in some cases (children who fail hearing screening or with abnormalities compatible with cCMV in physical exams).

The main focus of the study is to identify patient and treatment characteristics that are associated with outcome. This will allow improved patient care in the future.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Measuring cases of cCMV in the UK

    Time frame: 15 years

    To analyze the epidemiology of children born with cCMV

  2. Clinical characteristics

    Time frame: 15 years

    To analyze the clinical characteristic of children born with cCMV (measure is number of participants with hearing loss, retinitis, neurological abnormalities, skin rashes, or hepatosplenomegaly)

  3. To evaluate risk factors in children with cCMV for long term sequelae

    Time frame: 15 years

    To measure the number of cases with abnormal brain imaging (cranial USS or MRI), hearing loss, retinitis or anaemia, leucopenia, thrombocytopenia, renal function or liver abnormalities at diagnosis

  4. Adverse events

    Time frame: 15 years

    To document adverse events of different treatment strategies

  5. To evaluate the prognostic value of microbiological variables

    Time frame: 15 years

    To measure the urine CMV viral load in cases at diagnosis who develop hearing loss

  6. To evaluate the prognostic value of image findings

    Time frame: 15 years

    To measure the number of cases who have abnormal brain imaging (cranial USS or MRI) at diagnosis and develop hearing loss

  7. To evaluate associated outcomes with different treatment strategies

    Time frame: 15 years

    To measure the number of cases treated with valganciclovir and the number of treated cases who need a treatment break

Study contacts

Contact information is provided by the study sponsor or research team.

Sana Ibrahim, BSc

CONTACT

[email protected]

+44 (0)208 725 5382

Sponsors and collaborators

Lead sponsor

St George's, University of London

Other

Collaborators

  • European Society for Paediatric Infectious Diseases

Registry information

Acronym: cCMVnet

Important dates

Study start
2023
Primary completion
2031
Study completion
2038
First posted
May 12, 2023
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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