European Pregnancy and Paediatric Infections Cohort Collaboration: Paediatric Protocol

Summary

Across Europe and worldwide, there are many studies following groups (cohorts) of children living with human immunodeficiency virus (HIV) and other infections over time, to monitor their long-term health. Some of these infections are rare: for example, few children in Western Europe are living with HIV, so the studies often have fairly small numbers of participants. This can make it difficult to answer research questions in these cohorts and means that doctors and researchers working with these patients in different countries need to work together. This is particularly important as children are not often included in clinical trials of treatments and other interventions.

The European Pregnancy and Paediatric Infections Cohort Collaboration (EPPICC) is an international network of researchers working together in this way. Researchers in the network represent cohort studies of pregnant women and children with, or at risk of, infections from across Europe and Thailand. The research focuses on infections in pregnant women and children, particularly HIV, hepatitis B and C virus, and tuberculosis, and, from 2020, novel coronavirus (COVID-19). By combining data from many cohorts, the researchers aim to answer questions that could not be answered by one study individually (for example, because a large number of pregnant women or children are needed to answer the question).

This protocol focuses on the paediatric component of EPPICC's research, which focuses on the treatment of children at risk of and living with infections. For example, what medicines are used most often and how do they affect children's health? EPPICC is an observational study, which means that children do not receive any extra treatment as part of the study. Instead, children are "observed" during their routine medical care. Each cohort keeps records of the children's health collected at routine clinic visits, including information such as date of birth and sex, results of diagnostic tests, treatments received, and any illnesses or other events that the children have had. The EPPICC study combines and analyses data from all of the cohorts that take part, to answer questions about the risks and benefits of different diagnosis or treatment strategies, the long-term effects of infection and treatment during childhood and young adulthood, and regional variations (e.g. between Western and Eastern Europe) in the risk and management of infections.

All of the data collected through the EPPICC Paediatric Protocol are stored securely at the Medical Research Council Clinical Trials Unit (MRC CTU) at UCL. Data collection and storage are governed by the General Data Protection Regulation. A Steering Committee guides the research to make sure it is relevant and of high quality. Public and patient involvement (PPI) may be provided by individual cohorts' own groups, as well as by the interlinked Penta organisation, which is a network of paediatricians and researchers working in infections in Europe and globally. The PPI groups help with release of the results of the research. The results are also published on the Penta Foundation's public website (https://penta-id.org/), and presented at conferences and published in Open Access scientific journals.

Conditions

• HIV Infections
• Tuberculosis Infection
• Hepatitis C
• Covid19

Interventions

DRUG

ART Therapy

Sponsors & Collaborators

• University College, London

  collaborator OTHER

• Centre Hospitalier Universitaire Saint Pierre

  collaborator OTHER

• German Pediatric and Adolescent HIV Cohort (GEPIC), GERMANY

  collaborator UNKNOWN

• Greece Cohort, GREECE

  collaborator UNKNOWN

• Register for HIV infection in children, ITALY

  collaborator UNKNOWN

• ATHENA ,THE NETHERLANDS

  collaborator UNKNOWN

• Polish Paediatric Cohort, POLAND

  collaborator UNKNOWN

• HSM/CHLN Lisbon, PORTUGAL

  collaborator UNKNOWN

• Centro Hospitalar do Porto

  collaborator OTHER

• Victor Babes Hospital Cohort, Bucharest, ROMANIA

  collaborator UNKNOWN

• Republican Hospital of Infectious Diseases, St Petersburg, RUSSIA

  collaborator UNKNOWN

• Irkutsk AIDS Centre, RUSSIA

  collaborator UNKNOWN

• The City HIV Centre, St Petersburg, RUSSIA

  collaborator UNKNOWN

• CoRISpe-cat cohort of HIV-infected children, SPAIN

  collaborator UNKNOWN

• CoRISpe-S cohort of HIV-infected children, SPAIN

  collaborator UNKNOWN

• Karolinska Institutet

  collaborator OTHER

• Swiss Mother and Child HIV Cohort Study, SWITZERLAND

  collaborator UNKNOWN

• Programs for HIV Prevention and Treatment (PHPT), THAILAND

  collaborator UNKNOWN

• National Surveilliance of HIV in Pregnancy and Childhood and Collaborative HIV Paediatric Study (CHIPS)

  collaborator UNKNOWN

• Collaborative HIV Paediatric Study (CHIPS)

  collaborator UNKNOWN

• Ukraine Paediatric HIV Cohort, UKRAINE

  collaborator UNKNOWN

• PENTA Foundation

  lead NETWORK

Eligibility

Max Age

17 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-01-01

Primary Completion

2020-11-11

Completion

2025-01-01