Pediatric Reference Intervals in China (PRINCE) is a nationwide initiative that aims to establish and validate harmonized reference intervals (RIs) for Chinese children and adolescents, in which 15,150 healthy volunteers aged up to 20 years were recruited from 11 centers to establish RIs and 7,557 children and adolescents were enrolled from 21 centers to validate RIs.
The complete blood cell counts (CBC) of venous whole blood were measured by hematology analyzers through Sysmex systems in different centers. Age- and sex-specific RIs were calculated according to the guidelines.
Unlike adults with certain levels of analyte concentrations, hematological parameters of children changed through growth and development. Red blood cell counts, hemoglobin, and hematocrit increased with age, and revealed higher concentrations in boys than girls after puberty. White blood cell counts and platelet counts showed significant higher levels than adults before 2 years of age, and then gradually decreased without distinct sex differences. In addition, lymphocyte counts decreased with age while neutrophil counts showed an opposite trend. The lower and upper limits of pediatric RIs of CBC were different from those of adults.
The validation of RIs indicated that the PRINCE study provided a version of RIs suitable for most of regions in China. This first harmonized pediatric RIs of CBC across China provided a robust database to understand the dynamic changes of hematologic parameters from birth to adolescence, and will contribute to clinical diagnosis and prognosis evaluation for pediatric patients as well.
Funding source: The Medical Hospital Authority, National Health Commission of the People's Republic of China
Award Identifier / Grant number: No. 2017374
We thank Dr. Ali Abbas for his help in language polishing. We thank all of the members of workgroups in 11 medical centers for their hard work in participant recruitment and sample collection. At last, we specially thank all of the healthy children volunteers and their family.
Research funding: This study was supported by the grant from the Medical Hospital Authority, National Health Commission of the People’s Republic of China (No. 2017374).
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Competing interests: Authors state no conflict of interest.
Informed consent: Informed consent was obtained from each participant’s legally authorized representative (parent or guardian) in the case of the child aged less than 8 years. Otherwise, the informed consent was obtained from both the child and his/her legally authorized representative.
Ethical approval: The PRINCE study was approved by The Institutional Review Board of Beijing Children’s Hospital (2016-53). At the same time, the protocol was approved by the institutional review boards of other 10 collaborating centers.
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