Biomarkers of Acute Serious Illness in Children

NCT03238040 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 674

Last updated 2022-10-04

No results posted yet for this study

Summary

This study is a large multi-centre collaboration between a busy regional paediatric intensive care transport service (Children's Acute Transport Service, CATS), four large paediatric intensive care units (PICUs at Great Ormond Street Hospital, St Mary's Hospital and Royal London Hospital in London, and Addenbrookes Hospital in Cambridge) and the Department of Paediatrics at Imperial College, London. CATS transports over 800 sick children on life support to the three PICUs each year.

We aim to improve our understanding of the genetic basis and biological pathways by which children with acute infection or injury become critically ill and develop failure of vital organs, and how these factors influence outcome. We will establish well-characterised cohorts of sick children with diverse pathologies, in whom blood, urine and other samples will be collected at an early stage of critical illness. Samples will be analysed using genomic, transcriptomic, proteomic and metabolomic approaches. Advanced bioinformatics techniques will be used to identify biomarkers for early diagnosis and robust risk stratification. We will focus on biomarkers to help distinguish between serious bacterial infections, viral infections and other causes of critical illness; diagnose incipient organ failure; and accurately identify, early on, children at high risk of developing a poor outcome.

We will recruit critically ill children at first contact with the CATS team, during emergency transport to PICU. Due to the emergency nature of the research, and minimal risk associated with the study procedure, we will seek deferred, written informed consent from parents/guardians once their child has been stabilised, within 24-48 hours following PICU admission.

By studying these important questions, we aim to better understand how we can diagnose and provide early life-saving treatments to critically ill children. The research team have an established track record of successful completion of several large clinical studies in critical care as well as validation of biomarkers in other diseases.

Conditions

  • Critical Illness
  • Infection, Mixed
  • Children, Only

Interventions

OTHER

None, observational study

Observational study, no interventions

Sponsors & Collaborators

  • Imperial College London

    collaborator OTHER
  • Barts & The London NHS Trust

    collaborator OTHER
  • Imperial College Healthcare NHS Trust

    collaborator OTHER
  • University of Cambridge

    collaborator OTHER
  • Great Ormond Street Hospital for Children NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Padmanabhan Ramnarayan · Children's Acute Transport Service, Great Ormond Street Hospital

Eligibility

Min Age
0 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-01
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03238040 on ClinicalTrials.gov