The PedNet Haemophilia Registry is a database containing observational data of children with haemophilia A and B. The PedNet Haemophilia Registry is owned and administered by the PedNet Haemophila Research Foundation. The office of the study staff is located in Baarn, The Netherlands.
As of December 1st 2016, the PedNet Registry is registered on http://ClinicalTrials.gov under the number NCT02979119. ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. The PedNet Registry is also registered in the European Union electronic Register of Post-Authorisation Studies (PAS) of the European Network of Centres for Pharmacovigilance (ENCePP).
Aim
The aim of the PedNet Registry is to include complete cohorts of all newly diagnosed patients who are born from January 1st 2000 with congenital haemophilia A and B with clotting factor VIII/ IX levels ≤ 0.25 IU/ dl and are treated in one of the 34 participating centres in 19 countries.
Design & Protocol
In 2014 an article was published about the PedNet Registry and its design click here
Complete information about the rationale, objectives, methods, procedures (including data protection) and the complete list of collected variables are described in the PedNet Protocol.
Data Collection
Parents of the patients receive written and verbal information from their physician about the registry and sign informed consent before inclusion in the PedNet Registry is completed. Detailed information on diagnosis, clinical symptoms and haemophilia treatment, side effects and long term outcome are collected in the centres from diagnosis onward. Data entry continues throughout the year by data registrars in the participating centres using a web-based Case Report Form (CRF).
Selection bias is prevented by inclusion of all eligible patients diagnosed in the centre and implementation of strict in- and exclusion criteria.
Number of Inclusions
On January 1st 2023 a total of 2759 children were included in the Registry. More information you can find on Keynumbers. A complete annual report on the status of the PedNet Registry, research and publications can be found here.
Monitoring
Monitoring of the source data in the centres is performed by external monitors according to a monitor plan. For all patients, 100% of baseline data are monitored and at least 10% of follow up forms.