European Paediatric Contrast-enhanced Ultrasound Database
Research type
Research Database
IRAS ID
164664
Contact name
Paul Sidhu
Contact email
Research summary
European Paediatric Contrast Enhanced Ultrasound
REC name
South West - Central Bristol Research Ethics Committee
REC reference
16/SW/0042
Date of REC Opinion
1 Feb 2017
REC opinion
Further Information Favourable Opinion
Data collection arrangements
The use of CEUS in paediatric patients is not regulated, as the product used, the contrast agent (SonoVue, Bracco SpA, Milan), is not licensed for use in paediatric patients. However, it is acceptable that with physician responsibility, good evidence of the efficacy of an agent, administrating a non-licensed agent is approved by the medical regulatory authorities in many countries (including the UK). This is true of 70% of drugs administered to children, where there is no license for children (includes salbutamol, amoxicillin).The Patient Study Data Registry at www.efsumb-data.org is the input database. The design of the database, allows several levels of access. i) Access to input data on individual patients, will allow only the single patient to be viewed. ii) Access to a small group of researchers, based in the UK and Germany, where all data will be anonymised and no patient names are visible. iii) Access to One investigator (P. Sidhu) who leads in the UK. We plan to formalise this by setting up a database across Europe to record all the times ultrasound contrast (CEUS) is used, and present the results as a publication to allow doctors to use CEUS in children with the backup of scientific data.
Research programme
The efficacy and safety of the use of contrast-enhanced ultrasound (CEUS) in the paediatric population.This application is to allow establishment of a database accessed by a small number of reviewers for collation of data. Anonymised data will be available to all except Prof P Sidhu, who will have access to a password controlled area where the patient's ID will be visible, to allow feedback to the submitting centre, where the patient will be identified. We hope to achieve this by allowing practitioners to register the use of CEUS with a reliable and well maintained database. The entries to this database will allow the identification of the patient by a single user ( Prof P Sidhu based in the UK) and any other access by a small number of responsible medical users in Germany will be restricted to anonymised data.
Research database title
European Paediatric Contrast Enhanced Ultrasound
Establishment organisation
King's College Hospital
Establishment organisation address
Prof Paul Sidhu
Department of Radiology
King's College Hospital, Denmark Hill, London
SE5 9RS