Clinical laboratory reference values amongst children aged 4 weeks to 17 months in Kilifi, Kenya: A cross sectional...

Area of Science:

• Clinical Laboratory Science
• Pediatric Health
• Global Health

Background:

• Reference intervals for clinical laboratory parameters are crucial for clinical trials, but current standards often lack region-specific data, particularly for sub-Saharan Africa.
• Existing haematological and biochemical parameters used in trials are typically derived from industrialized nations or non-region-specific WHO references.
• This gap can lead to inaccurate assessments of eligibility, toxicity, and adverse events in pediatric populations in low and middle-income countries.

Purpose of the Study:

• To establish community-derived reference values for haematological and biochemical parameters in children aged 4 weeks to 17 months in Kilifi, Kenya.
• To provide region-specific data that can improve the accuracy of clinical trial assessments in this population.
• To compare established reference ranges with those from developed countries and other African regions.

Main Methods:

• A cross-sectional study was conducted, nested within Phase II and III trials of the RTS, S malaria vaccine candidate.
• Analysis included 10 haematological and 2 biochemical parameters from 1,070 and 423 healthy community children, respectively, prior to experimental vaccine administration.
• Statistical analysis followed Clinical and Laboratory Standards Institute EP28-A3c guidelines, determining 95% reference ranges and 90% confidence intervals using non-parametric methods.

Main Results:

• Established age-partitioned reference ranges for haematological parameters (4 weeks to <6 months, 6 months to <12 months, 12 months to 17 months) and biochemical parameters (4 weeks to 17 months).
• No significant gender differences were observed for any parameters across all age groups.
• While some parameters like Hemoglobin (Hb), Mean Corpuscular Volume (MCV), and platelets largely overlapped with US/European ranges, significant differences were noted in the lower limits of Hb, Hematocrit (Hct), and platelets, and the upper limit of platelets and Hct.

Conclusions:

• Community norms for common haematological and biochemical parameters in Kenyan children differ from those established in developed countries.
• The findings underscore the critical need for locally derived reference values in clinical trials conducted in low and middle-income countries.
• Utilizing region-specific data ensures more accurate detection of deviations from usual values, improving trial safety and efficacy assessments.