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  • A prospective, cross-sectional study to establish age-specific reference intervals for neonates and children in the setting of clinical biochemistry, immunology and haematology: the HAPPI Kids study protocol

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Paediatrics
Protocol
A prospective, cross-sectional study to establish age-specific reference intervals for neonates and children in the setting of clinical biochemistry, immunology and haematology: the HAPPI Kids study protocol
  1. Monsurul Hoq1,2,
  2. Vicky Karlaftis3,
  3. Susan Mathews4,
  4. Janet Burgess5,
  5. Susan M Donath1,2,
  6. John Carlin1,2,
  7. Paul Monagle2,3,
  8. Vera Ignjatovic2,3
  1. 1 Department of Clinical Epidemiology and Biostatistics Unit, Murdoch Children’s Research Institute, Parkville, Victoria, Australia
  2. 2 Department of Paediatrics, The University of Melbourne, Parkville, Victoria, Australia
  3. 3 Department of Haematology Research, Murdoch Children’s Research Institute, Parkville, Victoria, Australia
  4. 4 Department of Biochemistry, Laboratory Services, The Royal Children’s Hospital, Parkville, Victoria, Australia
  5. 5 Department of Pathology Collection, Laboratory Services, The Royal Children’s Hospital, Parkville, Victoria, Australia
  1. Correspondence to Dr Vera Ignjatovic; vera.ignjatovic{at}mcri.edu.au

Abstract

Introduction The clinical interpretation of laboratory tests is reliant on reference intervals. However, the accuracy of a reference interval is dependent on the selected reference population, and in paediatrics, the ability of the reference interval to reflect changes associated with growth and age, as well as sex and ethnicity. Differences in reagent formulations, methodologies and analysers can also impact on a reference interval. To date, no direct comparison of reference intervals for common analytes using different analysers in children has been published. The Harmonising Age Pathology Parameters in Kids (HAPPI Kids) study aims to establish age-appropriate reference intervals for commonly used analytes in the routine clinical care of neonates and children, and to determine the feasibility of paediatric reference interval harmonisation by comparing age-appropriate reference intervals in different analysers for multiple analytes.

Methods and analysis The HAPPI Kids study is a prospective cross-sectional study, collecting paediatric blood samples for analysis of commonly requested biochemical, immunological and haematological tests. Venous blood samples are collected from healthy premature neonates (32–36 weeks of gestation), term neonates (from birth to a maximum of 72 hours postbirth) and children aged 30 days to ≤18 years (undergoing minor day surgical procedures). Blood samples are processed according to standard laboratory procedures and, if not processed immediately, stored at –80°C. A minimum of 20 samples is analysed for every analyte for neonates and then each year of age until 18 years. Analytical testing is performed according to the standard operating procedures used for clinical samples. Where possible, sample aliquots from the same patients are analysed for an analyte across multiple commercially available analysers.

Ethics and dissemination The study protocol was approved by The Royal Children’s Hospital, Melbourne, Ethics in Human Research Committee (34183 A). The study findings will be published in peer-reviewed journals and shared with clinicians, laboratory scientists and laboratories.

  • paediatrics
  • neonates
  • children
  • reference intervals

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi-org.ezproxy.u-pec.fr/10.1136/bmjopen-2018-025897

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    Footnotes

    • Contributors MH wrote the manuscript and developed the statistical analysis plan. VK wrote the study protocol, obtained ethics approval for the study, cowrote the manuscript and is the coordinator of the study. SM provided biochemistry expertise in the design of the study and revised the manuscript. JB provided pathology collection expertise in the design of the study, training for the pathology collectors and reviewed the manuscript. JC and SMD provided support for statistical analysis plan and reviewed the manuscript. PM conceived the study and contributed to its design and was a major contributor in writing the manuscript. VI contributed to the design of the study and was a major contributor in writing the manuscript. All authors read and approved the final manuscript.

    • Funding This study has been primarily funded by The Royal Children’s Hospital Foundation (Proposal ID: 2014 – 233), with supplementary funding from Ortho Diagnostics. In addition, the study received in-kind reagents from Roche Diagnostics. Funding bodies do not have any input in the design of the study, sample collection, analysis and interpretation of data and in preparation of the manuscript.

    • Competing interests None declared.

    • Ethics approval The study protocol has been approved (34183 A) by The Royal Children’s Hospital, Melbourne, Ethics in Human Research Committee (HREC) and subsequently approved by the HREC committees of all participating hospitals including The Royal Women’s Hospital, Northern Health and Western Health—Sunshine Hospital.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Patient consent for publication Parental/guardian consent obtained.