Observational Study of the Management of Infants With Congenital CMV (cCMVnet)

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.

Study Overview

• Status: Recruiting
• Conditions: Congenital Cmv

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Sana Ibrahim, BSc; Phone Number: +44 (0)208 725 5382; Email: sibrahim@sgul.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, SW17 0RE
    • Recruiting
    • St George's University of London
    • Contact: Sana Ibrahim, BSc; Phone Number: +44 (0)208 725 5382; Email: sibrahim@sgul.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children will be identified at their routine healthcare attendance at the specialist clinics for children with congenital CMV at one of the participating centres. The person with parental responsibility will be approached to be informed about the registry and to request consent, either by the cCMVNET clinician or a delegated research nurse.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical characteristics	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)	15 years
Adverse events	To document adverse events of different treatment strategies	15 years
Measuring cases of cCMV in the UK	To analyze the epidemiology of children born with cCMV	15 years
To evaluate risk factors in children with cCMV for long term sequelae	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	15 years
To evaluate the prognostic value of microbiological variables	To measure the urine CMV viral load in cases at diagnosis who develop hearing loss	15 years
To evaluate the prognostic value of image findings	To measure the number of cases who have abnormal brain imaging (cranial USS or MRI) at diagnosis and develop hearing loss	15 years
To evaluate associated outcomes with different treatment strategies	To measure the number of cases treated with valganciclovir and the number of treated cases who need a treatment break	15 years

Collaborators and Investigators

• Sponsor: St George's, University of London
• Collaborators: European Society for Paediatric Infectious Diseases
• Investigators: Principal Investigator: Simon Drysdale, MD, St George's, University of London

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2023
• Primary Completion (Anticipated): March 30, 2031
• Study Completion (Anticipated): March 30, 2038

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Actual): May 12, 2023

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Herpesviridae Infections; Cytomegalovirus Infections
• Other Study ID Numbers: 2021.0118

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No