ECCI cCMV Database V2.0

  • Research type

    Research Database

  • IRAS ID

    211100

  • Contact name

    Suzanne E Luck

  • Contact email

    suzanne.luck@nhs.net

  • Research summary

    ECCI Congenital Cytomegalovirus Database Version 2.0

  • REC name

    London - Queen Square Research Ethics Committee

  • REC reference

    17/LO/0449

  • Date of REC Opinion

    3 May 2017

  • REC opinion

    Further Information Favourable Opinion

  • Data collection arrangements

    Data will be entered by individual centres that care for babies and children born with a diagnosis of confirmed congenital cytomegalovirus (CMV) infection in a standardised way onto this centralised database.
    Data will be electronically entered from clinical notes, correspondence, and investigation results accessible to clinicians as part of conducting standard clinical care. Data will be entered by the clinicians themselves or appropriately qualified, designated, members of their clinical (or research) teams.
    Individual clinicians will only be able to access data entered for cases entered by their own local team.
    The central study team will have access to all data entered electronically but will not directly be able to identify individuals entered onto the database since the only identifiable information held electronically will be date of birth.

    Information will be recorded on baseline clinical features, results of any measures of virus in blood, urine or other fluids (where recorded), treatment received, results of neuroimaging (any scans of the brain) and clinical, hearing and developmental progress over time. The aim will be to monitor progress and development of these children and any interventions or support received.

  • Research programme

    This database aims to provide further information on prognosis, treatment, side effects and outcomes in babies born with congenital CMV. Since individual centres see only a few babies a year with this condition national data collection is necessary to be able to fully evaluate the spectrum of problems encountered by these children and the beneficial (or harmful) effect of any interventions. The UK parent group for children with congenital CMV, CMV Action, have been consulted during the development of the database.

  • Research database title

    ECCI Congenital Cytomegalovirus Database Version 2.0

  • Establishment organisation

    St George's University London

  • Establishment organisation address

    St George's Joint Research Enterprise Office

    Hunter Wing, Ground Floor,

    Cranmer Terrace

    SW17 ORE