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Published on: January 29, 2018
Redefining normal bone and mineral clinical biochemistry reference intervals for healthy infants in Canada
Sina Gallo1, Kathyrn Comeau2, Atul Sharma3
1School of Dietetics and Human Nutrition, McGill University, Montréal, Québec H9X 3V9, Canada; Nutrition and Food Studies, George Mason University, Fairfax, VA 22030, USA.
Insights
Establishing infant reference intervals for clinical chemistry markers like calcium and creatinine is crucial. This study provides age-specific data for infants aged 1 to 12 months, aiding pediatric diagnostics.
Area of Science:
- Pediatric Clinical Chemistry
- Infant Physiology
- Biochemical Reference Intervals
Background:
- Limited normative data for routine clinical chemistry in healthy term infants hinders accurate diagnosis.
- Physiological changes in infants significantly impact biochemical markers, necessitating age-specific reference ranges.
Purpose of the Study:
- To establish reference intervals for key clinical chemistry analytes in infants aged 1 to 12 months.
- Define age-specific values for calcium, phosphate, creatinine, and alkaline phosphatase in healthy term infants.
Main Methods:
- Secondary analysis of 132 infants from a vitamin D3 supplementation trial (NCT00381914).
- Serial collection of capillary and urine samples for biochemical analysis.
- Measurements included plasma and whole-blood ionized calcium, phosphate, creatinine, and alkaline phosphatase.
Main Results:
- Significant temporal changes observed in all measured analytes (p<0.05) with no sex-based differences.
- Decreases in whole-blood ionized calcium, plasma calcium, phosphate, alkaline phosphatase, and urinary calcium:creatinine from 1 to 12 months.
- Plasma creatinine levels increased; some values exceeded adult reference limits, highlighting the need for infant-specific data.
Conclusions:
- Age-specific reference values are essential for infants due to significant analyte changes between 1 and 12 months.
- The generated data and smoothed centile curves (LMS method) address gaps in normative data.
- These findings will aid in creating new reference intervals, improving diagnostic accuracy and care for infants.
Background:
Few normative data exist for routine clinical chemistry in healthy term infants, that is, during a time of rapid development. Biochemical markers are significantly affected by these physiological changes and the lack of appropriate reference intervals may impede diagnostics in infants.
Objective:
To define reference intervals for calcium, phosphate, creatinine, and alkaline phosphatase in infants from 1 to 12 months of age.
Design And Methods:
This was an unblinded secondary analysis of 132 breastfeeding infants participating in a vitamin D3 supplementation trial (400-1600IU/d) followed prospectively until 1 year of age (NCT00381914). Serial non-fasting capillary and spot urine samples were collected for the measurement of plasma calcium, phosphate, creatinine, and alkaline phosphatase; urinary calcium, phosphate and creatinine (DxC600 Beckman Coulter); and whole-blood ionized calcium (ABL 725 Radiometer). All visits were conducted at McGill University in Montréal, Canada.
Results:
All analytes changed significantly over time (p<0.05), but there was no effect of sex. From 1 to 12 months, values decreased for whole-blood ionized calcium; plasma calcium, phosphate, and alkaline phosphatase; and urinary calcium:creatinine. Plasma creatinine increased. For some analytes, particularly calcium and alkaline phosphatase, values were often above the 'typical' adult or older child reference limits. Smoothed centile curves (LMS method) were developed to fill existing gaps in normative data for these analytes.
Conclusions:
Most analytes showed a significant change from 1 to 12 months, confirming the need for age-specific reference values. These data can assist in the generation of new reference intervals for healthy term infants and ultimately improve the care of children.
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