Project goals
Establish a comprehensive database of reference ranges for blood test results in Vietnamese children and adolescents.
- Establish age- and sex-specific reference intervals for biochemical indicators in infants and children from 30 days old to 18 years old.
- Establish age- and sex-specific reference intervals for some endocrine markers and reproductive hormones in infants and children from 30 days old to 18 years old.
- Establish age- and sex-specific reference intervals for hematological and coagulation indices in infants and children from 30 days old to 18 years old.
- Establish continuous reference intervals for some biochemical indicators, some endocrine markers, reproductive hormones, hematological markers and common blood coagulation in infants and children from 30 days old to 18 years old.
Main tasks of the project
Select the study population
Children from birth to 18 years of age are eligible to participate in this research project, with written informed consent from their guardian. Sampling locations of 63 provinces and cities of Vietnam: with 7 geographical regions, 1 province will be selected for each region.
Through a community-based approach, events will be held at schools, community centers, kindergartens and special community clinics to create opportunities for children across Hanoi and some Provinces and cities across Vietnam to participate. Inclusion criteria for the study were determined by questionnaire, requesting information on chronic and acute medical history, prescription and non-prescription drug use, diet and ethnicity. Subjects were excluded from the study if they reported: 1) history of chronic or metabolic disease, 2) acute illness in the past month, and 3) prescription drug use in the past month.
Collect and analyze samples
Sample size: The expected sample size is at least 1680 healthy children, divided into 6 groups according to the child’s developmental stages, each group has at least 260 subjects, males and females in each group are equivalent. The six groups include: newborns (0-3 months), infants (4-11 months), toddlers (1-2 years old), preschoolers (3-5 years old), school age (6- 13 years old), teenagers and adolescents (14-18 years old).
Depending on the child’s age, 2 mL to 10 mL of whole blood will be collected in appropriate collection tubes depending on the test by professional pediatric phlebotomists trained in standard practice procedures. Blood samples for biochemical, immunological, and coagulation tests were centrifuged at 4000 rpm for 10 minutes within four hours after collection, divided into frozen vials of 0.5 mL or 1.5 mL and stored at -80°C. Blood samples for blood cell testing will be collected and performed within 24 hours of sampling.
Biomarkers
35 analytes including electrolytes, metabolites, proteins, enzymes. 12 immunological indexes, endocrine indexes and reproductive hormones. 25 basic hematological parameters. 3 basic blood coagulation indexes.
Sample processing and sample analysis
Pre-test sample processing will be completed within four hours of collection. Samples will be transported refrigerated in batches to the laboratory and analyzed along with regular patient samples. Samples will be analyzed on testing systems according to the manufacturer’s instructions and include servicing, maintenance, calibration and quality control.
Data analysis and statistics
A direct normalization approach will be used to establish all reference intervals. Reference intervals were calculated based on CLSI guidelines (C28-A3). In parallel with the discrete reference intervals for each age group, continuous reference intervals will be established to accurately describe the fluctuations of biological markers for the developmental stages of children from birth to 18 years old.
