HAPPI Kids Study
- Project status: Active
Research area: Clinical Sciences > Haematology
Healthy babies and children for better diagnostics and research
HAPPI KIDS is a world-leading program dedicated to collecting, storing, and studying blood samples from healthy babies and children.
By defining what “normal” looks like, we empower researchers, clinicians, and industry partners to develop better diagnostics, safer treatments, and more effective therapies for children everywhere.
HAPPI KIDS is a world-leading program dedicated to collecting, storing, and studying blood samples from healthy babies and children.
By defining what “normal” looks like, we empower researchers, clinicians, and industry partners to develop better...
HAPPI KIDS is a world-leading program dedicated to collecting, storing, and studying blood samples from healthy babies and children.
By defining what “normal” looks like, we empower researchers, clinicians, and industry partners to develop better diagnostics, safer treatments, and more effective therapies for children everywhere.
Our research into the biology of aging holds the potential to reduce the burden of disease in adulthood.
The HAPPI KIDS biobank supports everything from age-specific diagnostic benchmarks to pre-clinical testing and clinical trial readiness. This ensures that healthcare for children is grounded in robust, age-appropriate evidence.
What is the challenge facing children and adolescents?
Without accurate data from healthy children:
- Blood tests may be incorrectly flagged as abnormal
- Treatments may be delayed or misdirected
- Diagnostic tools and medicines may not be optimised for children
HAPPI KIDS exists to close this healthcare gap
By defining healthy ranges and providing high-quality samples for research and development, we accelerate the discovery of safer, more effective diagnostics and therapies for babies and children around the world.
Importantly many adult diseases are believed to begin before birth (prenatally). That’s why early-life research is essential. To ensure biomarkers are clinically useful, we must first understand their role across development and aging.
Our services & capabilities
Samples we collect:
- Plasma
- Whole blood
- Peripheral Blood Mononuclear Cell (PBMC)
- Serum
In-house diagnostic testing, including:
- Research and development of novel tests and biomarkers
- Development of reference intervals for routine pathology tests
- In vitro drug testing across the paediatric age spectrum
- Provision of age-appropriate controls for rare disease testing
- Investigation of age-related changes linked to adult disease burden
- Comprehensive omics profiling
Our research team
- Professor Paul Monagle, Coordinating Principal Investigator, MCRI
- Ms Vicky Karlaftis, Study Coordinator, MCRI
Associate Investigators
- Dr Chantal Attard, Senior Research Fellow, MCRI
- Ms Janet Burgess, The Royal Children’s Hospital (RCH)
- Ms Jenny Ryan, The Royal Women’s Hospital (RWH)
Who can take part?
- Healthy children aged 28 days to 18 years who are attending hospital for minor elective surgery requiring a general anaesthetic.
- Healthy term babies born between 36 and 42 weeks' gestation.
- Healthy premature babies born after 28 weeks' gestation.
- Adults
Blood samples are collected by specially trained neonatal and paediatric pathology collectors, following informed consent from families.
Where is the HAPPI Kids study taking place?
Participants are recruited at two leading hospitals in Melbourne, Victoria:
- The Royal Children’s Hospital (RCH)
- The Royal Women's Hospital
HAPPI KIDS brings together multiple research streams and collaborative partnerships to build a comprehensive platform for paediatric innovation.
Recruitment & sample collection
From healthy babies, children, and adolescents to provide the foundation for robust, age-specific data.
State-of-the-art biobanking
Secure, quality-controlled storage ensures samples remain viable for research.
Age-appropriate diagnostic reference ranges
Refining evidence-based benchmarks so clinicians can accurately interpret blood tests for every stage of childhood to reduce misdiagnosis and unnecessary interventions.
Pre-clinical testing
In-house programs evaluate emerging drugs and diagnostics, helping accelerate safe and effective innovation.
Clinical trial support
Supplying “normal” data that speeds up paediatric approvals and improves trial design.
Research & industry partnerships
Collaborating with diagnostics companies, pharmaceutical firms, and hospital networks to close gaps in care and advance children’s health globally.
By building this platform, HAPPI KIDS is helping transform paediatric healthcare to ensure diagnostics and treatments are developed with children at the heart.
Funding
Thank you to our supporters.
- The Royal Children’s Hospital Foundation (RCH 1000)
Collaborations
We collaborate with leading institutions worldwide, including:
Hospitals
- The Royal Children's Hospital
- The Royal Women's Hospital
- The Royal Melbourne Hospital
- Monash Medical Centre
- Northern Health
- Western Health
Research Institutes and Universities
- St. Vincent’s Institute of Medical Research
- Harry Perkins Institute of Medical Research
Diagnostic Laboratories
- Western Health
- ACL Pathology
- Dorevitch Pathology
- Melbourne Pathology
- Pathology Queensland
Industry Partners
- Bayer AG
- Ortho Clinical Diagnostics
- Diagnostica Stago
- Anthos Therapeutics
Hoq M, Canterford L, Matthews S, et al. Statistical methods used in the estimation of age-specific paediatric reference intervals for laboratory blood tests: A systematic review [published online ahead of print, 2020 Aug 12]. Clin Biochem. 2020;S0009-9120(20)30810-9.
https://doi.org/10.1016/j.clinbiochem.2020.08.002
Sezgin G., Monagle P., Loh T. P., et al. Clinical thresholds for diagnosing iron deficiency: comparison of functional assessment of serum ferritin to population based centiles. Scientific Reports. 2020; 10:18233
https://doi.org/10.1038/s41598-020-75435-5
Sezgin G., Li L., Westbrook J., Wearne E., et al. Influence of serum iron test results on the diagnosis of iron deficiency in children: a retrospective observational study. BMJ Open. bmjopen-2020-046865.
https://doi.org/10.1136/bmjopen-2020-046865
Hoq M, Karlaftis V, Mathews S, et al. 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. BMJ Open. 2019;9:e025897.
https://doi.org/10.1136/bmjopen-2018-025897
Hoq M, Matthews S, Karlaftis V, et al. Reference Values for 30 Common Biochemistry Analytes Across 5 Different Analyzers in Neonates and Children 30 Days to 18 Years of Age. Clinical Chemistry. Jan 2019, clinchem.2019.306431
https://doi.org/10.1373/clinchem.2019.306431
Hoq M, Matthews S, Karlaftis V, et al. Validation of the HAPPI Kids continuous age-specific paediatric reference intervals. Journal of Applied Laboratory Medicine. 2020.
https://doi.org/10.1093/jalm/jfaa045
Hoq M, Matthews S, Donath S et al. Paediatric Reference Intervals: Current Status, Gaps, Challenges and Future Considerations. Clin Biochem Rev. 2020;41(2):43-52. https://doi.org/10.33176/aacb-19-00036
Cai T et al. Reference Intervals for serum Cystatin C in Neonates and Children 30 Days to 18 years old. Pediatric Nephrology. https://doi.org/10.1007/s00467-020-04612-5
Lesmana A, Tian P, Karlaftis V, et al; Harmonising Age Pathology Parameters in Kids Study Team. Continuous reference intervals for leukocyte telomere length in children: the method matters. Clin Chem Lab Med. 2021 Mar 12. https://doi.org/10.1515/cclm-2021-0059
McCafferty C et al. Increased platelet activation in SARS-CoV-2 infected non-hospitalised children and adults, and their household contacts. Br J Haematol. 2021 Jun 7. https://doi.org/10.1111/bjh.17629
Cai et al. Protocol for the Investigation of Plasma and Whole Blood Clot Property of Fibrin Fiber Thickness Using Scanning Electron Microscopy. Methods Mol Biol. 2023;2663:775-786. https://doi.org/10.1007/978-1-0716-3150-1_49
McCafferty C et al. Fibrin clot characteristics and anticoagulant response in a SARS-CoV-2-infected endothelial model. EJHaem. 2022 Mar 22;3(2):326-334. https://doi.org/10.1002/jha2.325
Smith J et al, HAPPI Kids study team. Age partitioned and continuous upper reference limits for Ortho VITROS High Sensitivity Troponin I in a healthy paediatric cohort. Clin Chem Lab Med. 2022 Jul 4;60(9):1449-1454. https://doi.org/10.1515/cclm-2022-0344
Letunica N, Karlaftis V, Monagle P, Ignjatovic V. Newborn and Pediatric Reference Intervals for Coagulation Assays Using Novel Reagents. Thromb Haemost. 2022 Dec;122(12):2042-2044. Epub 2022 Nov 7. https://doi.org/10.1055/s-0042-1750412
Van Den Helm S, Letunica N, Barton R, et al. Changes in von Willebrand Factor Multimers, Concentration, and Function During Pediatric Extracorporeal Membrane Oxygenation. Pediatr Crit Care Med. 2023 Apr 1;24(4):268-276. Epub 2023 Jan 5. https://doi.org/10.1097/PCC.0000000000003198
Contact us
HAPPI Kids study
Murdoch Children's Research Institute
The Royal Children's Hospital
50 Flemington Road
Parkville VIC 3052
Australia
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Patients & families
Vicky Karlaftis, Study Coordinator
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Collaborations & services
Dr Chantal Attard, Investigator
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