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

ABSTRACT: Reference intervals for clinical laboratory parameters are important for assessing eligibility, toxicity grading and management of adverse events in clinical trials. Nonetheless, haematological and biochemical parameters used for clinical trials in sub-Saharan Africa are typically derived from industrialized countries, or from WHO references that are not region-specific. We set out to establish community reference values for haematological and biochemical parameters amongst children aged 4 weeks to 17 months in Kilifi, Kenya. We conducted a cross sectional study nested within phase II and III trials of RTS, S malaria vaccine candidate. We analysed 10 haematological and 2 biochemical parameters from 1,070 and 423 community children without illness prior to experimental vaccine administration. Statistical analysis followed Clinical and Laboratory Standards Institute EP28-A3c guidelines. 95% reference ranges and their respective 90% confidence intervals were determined using non-parametric methods. Findings were compared with published ranges from Tanzania, Europe and The United States. We determined the reference ranges within the following age partitions: 4 weeks to <6 months, 6 months to less than <12 months, and 12 months to 17 months for the haematological parameters; and 4 weeks to 17 months for the biochemical parameters. There were no gender differences for all haematological and biochemical parameters in all age groups. Hb, MCV and platelets 95% reference ranges in infants largely overlapped with those from United States or Europe, except for the lower limit for Hb, Hct and platelets (lower); and upper limit for platelets (higher) and haematocrit(lower). Community norms for common haematological and biochemical parameters differ from developed countries. This reaffirms the need in clinical trials for locally derived reference values to detect deviation from what is usual in typical children in low and middle income countries.

SUBMITTER: Gitaka J

PROVIDER: S-EPMC5426761 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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

Gitaka Jesse J Ogwang Caroline C Ngari Moses M Akoo Pauline P Olotu Ally A Kerubo Christine C Fegan Greg G Njuguna Patricia P Nyakaya Godfrey G Otieno Tuda T Mwambingu Gabriel G Awuondo Ken K Lowe Brett B Chilengi Roma R Berkley James A JA

PloS one 20170511 5

Reference intervals for clinical laboratory parameters are important for assessing eligibility, toxicity grading and management of adverse events in clinical trials. Nonetheless, haematological and biochemical parameters used for clinical trials in sub-Saharan Africa are typically derived from industrialized countries, or from WHO references that are not region-specific. We set out to establish community reference values for haematological and biochemical parameters amongst children aged 4 weeks ...[more]

PMID: 28493930

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Project description:There is an urgent need for reliable region-specific hematological reference values for clinical monitoring. Laboratory reference ranges are important for assessing study participant eligibility, toxicity grading and management of adverse events in clinical trials and clinical diagnosis. Most clinical laboratories in Kenya rely on hematological reference values provided by instrument manufacturers and/or textbooks, which are based on population from Europe or North America. The use of such values in medical practice could result in improper patient management, selection bias in selection of appropriate participants for clinical trials and flawed classification of the clinical adverse events when applied to African populations. The aim of this study was to establish local laboratory hematological reference values in infants aged 1 month to 17 months from Kombewa Sub-county that could be true representative of the existing rural population. The study participants in the current study were those who had previously been recruited from GSK-sponsored study. This study was a phase III, Double Blind, Randomized, GSK-sponsored, Malaria Vaccine Clinical Trial that was conducted in infants aged 1month to 17months. 1,509 participants were included in the study analysis. Data were partitioned into 3 different age groups (1-6 months[m], 6-12 m and 12-17 m) and differences between gender were compared within each group. Data were analyzed using Graphpad prism V5 to generate 95% reference ranges (2.5th-97.5th percentile). There was evidence of gender differences in hemoglobin values (p = 0.0189) and platelet counts (p = 0.0005) in the 1 to 6m group. For the 12-17m group, there were differences in MCV (p<0.0001) and MCH (p = 0.0003). Comparing gender differences for all age groups, differences were noted in percent lymphocytes (p = 0.0396), percent monocytes (p = 0.0479), percent granulocytes (p = 0.0044), hemoglobin (p = 0.0204), hematocrit (p = 0.0448), MCV (p = 0.0092), MCH (p = 0.0089), MCHC (p = 0.0336) and absolute granulocytes (p = 0.0237). In 1 to 6m age group and all age groups assessed, for WBCs, hemoglobin, hematocrit, MCV and lymphocytes absolute counts, both 2.5th and 97.5th percentiles for Kisumu infants were higher than those from Kilifi. Platelet ranges for Kisumu children were narrower compared to Kilifi ranges. Kisumu hematology reference ranges were observed to be higher than the ranges of Tanzanian children for the WBCs, absolute lymphocyte and monocyte counts, hemoglobin, hematocrit and MCV. Higher ranges of WBCs, absolute lymphocyte and monocyte counts were observed compared to the values in US/Europe. Wider ranges were observed in hemoglobin, hematocrit, and MCV. Wider ranges were observed in platelet counts in Kisumu infants compared to the US/Europe ranges. Compared to Harriet Lane Handbook reference values that are used in the area, higher counts were observed in WBC counts, both absolute and percent lymphocyte counts, as well as monocyte counts for current study. Wider ranges were observed in RBC, platelets and RDW, while lower ranges noted in the current study for hemoglobin, hematocrit and granulocyte counts. This study underscores the importance of using locally established hematology reference ranges of different age groups in support of proper patient management and for clinical trials.

Project description:Objectives It is known that high altitude influences the growth metrics of high-altitude residents. Using a WHO-recommended standard, the research aimed to establish growth and development reference values for children of Tibetan ethnicity between the ages of 6 and 17 years old. Methods The measurements took place in Jomda County, Tibet with an average altitude of 3,650 m above sea level. A total of 3,955 observations (1,932 boys and 2,023 girls) were utilized to model the centile estimations. Included in the measurements are height, weight, body mass index, heart rate, blood pressure, forced lung capacity, sit and reach, and standing long jump. The measurements were modeled using the generalized additive models for location, scale, and shape (GAMLSS). Models were fitted with suitable distributions and locally smoothed using the P-spline for each GAMLSS hyper-parameter. Using the smallest Schwarz Bayesian criterion, the optimal model for each measurement was selected. After model adjustment, centile estimations were calculated for each model. Results Compared to the height reference values at the 50th percentile for multi-ethnic Chinese children residing at low altitudes, Tibetan ethnic children exhibit apparent stunted growth. In terms of forced vital capacity, it is remarkable that Tibetan ethnic children lag behind multi-ethnic Chinese children residing at low altitudes. Heart rate and blood pressure regulation are generally normal. Centile estimations are provided in this article and tabulated centiles (1p, 3p, 5p, 15p, 25p, 50p, 75p, 85p, 95p, 97p, 99p) in Chinese, Tibetic, and English are openly available in FigShare (doi: 10.6084/m9.figshare.20898196.v1). Conclusion This study established the first GAMLSS based growth and development reference values for Tibetan ethnic children aged 6–17. These reference values have numerous clinical and scientific applications. We offer Chinese policymakers with practical initiatives to further enhance the health of Tibetan ethnic children.

Project description:ObjectivesWristband activity trackers (accelerometers) could serve as a convenient monitoring tool to continuously quantify physical activity throughout the day. We aim to provide reference values for the use of these devices in healthy children.MethodsChildren were recruited at a local school and provided with activity trackers (Fitbit Charge 2). Pupils were instructed to wear devices during all normal daytime activities over a period of 11-15 days. Demographic data, total number of daily steps and heart rate were recorded. In addition, all children/parents were asked to complete a questionnaire providing information about daily physical routine (mode of transport to school, sporting activities as well as sport club memberships).ResultsThree hundred two children (54.6% boys; median age 8.7 years) participated in this prospective study. Median wearing time of the device was 12.1 h/day. Overall, the median daily total step count was 12,095. Median step counts/day were significantly higher in boys compared to girls (13,015 vs. 11,305 steps/day; p < 0.0001). In addition, step counts were significantly higher during the week, compared to weekend days. The effect of age on daily step count was found to be non-linear: the total daily step count increased from 6 to 8.5 years of age, while older children (aged >8.5 years) had lower step counts compared to the younger children. Significant predictors of the daily step count were male gender (+1,324.9 steps, p = 0.0008), mode of transportation to school (walking, bicycle, scooter: +865.5 steps p = 0.049), active membership in a sports club (+1,324.9 steps/day, p = 0.0008), and number of structured units of physical exercise performed (+336.5/per 45 min, p < 0.0001). Severe obesity was associated with a significant reduction in total daily step count (-3037.7 steps/day, p = 0.015).ConclusionOur prospective cohort study of healthy school children provides reference values for wristband accelerometers in normal individuals. In addition, it clarifies the effect of age, body weight and lifestyle on normal daily step counts in school children. This data should be helpful to judge the degree of physical limitation of patients compared to healthy peers.

Dataset Information

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

Publications

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

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