Clinical laboratory reference values amongst children aged 4 weeks to 17 months in Kilifi, Kenya: A cross sectional observational study.
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 indus...
| Main Authors: | , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Public Library of Science (PLoS)
2017-01-01
|
| Series: | PLoS ONE |
| Online Access: | http://europepmc.org/articles/PMC5426761?pdf=render |
| _version_ | 1818517691652112384 |
|---|---|
| author | Jesse Gitaka Caroline Ogwang Moses Ngari Pauline Akoo Ally Olotu Christine Kerubo Greg Fegan Patricia Njuguna Godfrey Nyakaya Tuda Otieno Gabriel Mwambingu Ken Awuondo Brett Lowe Roma Chilengi James A Berkley |
| author_facet | Jesse Gitaka Caroline Ogwang Moses Ngari Pauline Akoo Ally Olotu Christine Kerubo Greg Fegan Patricia Njuguna Godfrey Nyakaya Tuda Otieno Gabriel Mwambingu Ken Awuondo Brett Lowe Roma Chilengi James A Berkley |
| author_sort | Jesse Gitaka |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-11T00:59:41Z |
| format | Article |
| id | doaj.art-2e27172a13874a00a7cef93c3d9b4366 |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-12-11T00:59:41Z |
| publishDate | 2017-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-2e27172a13874a00a7cef93c3d9b43662022-12-22T01:26:22ZengPublic Library of Science (PLoS)PLoS ONE1932-62032017-01-01125e017738210.1371/journal.pone.0177382Clinical laboratory reference values amongst children aged 4 weeks to 17 months in Kilifi, Kenya: A cross sectional observational study.Jesse GitakaCaroline OgwangMoses NgariPauline AkooAlly OlotuChristine KeruboGreg FeganPatricia NjugunaGodfrey NyakayaTuda OtienoGabriel MwambinguKen AwuondoBrett LoweRoma ChilengiJames A BerkleyReference 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.http://europepmc.org/articles/PMC5426761?pdf=render |
| spellingShingle | Jesse Gitaka Caroline Ogwang Moses Ngari Pauline Akoo Ally Olotu Christine Kerubo Greg Fegan Patricia Njuguna Godfrey Nyakaya Tuda Otieno Gabriel Mwambingu Ken Awuondo Brett Lowe Roma Chilengi James A Berkley Clinical laboratory reference values amongst children aged 4 weeks to 17 months in Kilifi, Kenya: A cross sectional observational study. PLoS ONE |
| title | Clinical laboratory reference values amongst children aged 4 weeks to 17 months in Kilifi, Kenya: A cross sectional observational study. |
| title_full | Clinical laboratory reference values amongst children aged 4 weeks to 17 months in Kilifi, Kenya: A cross sectional observational study. |
| title_fullStr | Clinical laboratory reference values amongst children aged 4 weeks to 17 months in Kilifi, Kenya: A cross sectional observational study. |
| title_full_unstemmed | Clinical laboratory reference values amongst children aged 4 weeks to 17 months in Kilifi, Kenya: A cross sectional observational study. |
| title_short | Clinical laboratory reference values amongst children aged 4 weeks to 17 months in Kilifi, Kenya: A cross sectional observational study. |
| title_sort | clinical laboratory reference values amongst children aged 4 weeks to 17 months in kilifi kenya a cross sectional observational study |
| url | http://europepmc.org/articles/PMC5426761?pdf=render |
| work_keys_str_mv | AT jessegitaka clinicallaboratoryreferencevaluesamongstchildrenaged4weeksto17monthsinkilifikenyaacrosssectionalobservationalstudy AT carolineogwang clinicallaboratoryreferencevaluesamongstchildrenaged4weeksto17monthsinkilifikenyaacrosssectionalobservationalstudy AT mosesngari clinicallaboratoryreferencevaluesamongstchildrenaged4weeksto17monthsinkilifikenyaacrosssectionalobservationalstudy AT paulineakoo clinicallaboratoryreferencevaluesamongstchildrenaged4weeksto17monthsinkilifikenyaacrosssectionalobservationalstudy AT allyolotu clinicallaboratoryreferencevaluesamongstchildrenaged4weeksto17monthsinkilifikenyaacrosssectionalobservationalstudy AT christinekerubo clinicallaboratoryreferencevaluesamongstchildrenaged4weeksto17monthsinkilifikenyaacrosssectionalobservationalstudy AT gregfegan clinicallaboratoryreferencevaluesamongstchildrenaged4weeksto17monthsinkilifikenyaacrosssectionalobservationalstudy AT patricianjuguna clinicallaboratoryreferencevaluesamongstchildrenaged4weeksto17monthsinkilifikenyaacrosssectionalobservationalstudy AT godfreynyakaya clinicallaboratoryreferencevaluesamongstchildrenaged4weeksto17monthsinkilifikenyaacrosssectionalobservationalstudy AT tudaotieno clinicallaboratoryreferencevaluesamongstchildrenaged4weeksto17monthsinkilifikenyaacrosssectionalobservationalstudy AT gabrielmwambingu clinicallaboratoryreferencevaluesamongstchildrenaged4weeksto17monthsinkilifikenyaacrosssectionalobservationalstudy AT kenawuondo clinicallaboratoryreferencevaluesamongstchildrenaged4weeksto17monthsinkilifikenyaacrosssectionalobservationalstudy AT brettlowe clinicallaboratoryreferencevaluesamongstchildrenaged4weeksto17monthsinkilifikenyaacrosssectionalobservationalstudy AT romachilengi clinicallaboratoryreferencevaluesamongstchildrenaged4weeksto17monthsinkilifikenyaacrosssectionalobservationalstudy AT jamesaberkley clinicallaboratoryreferencevaluesamongstchildrenaged4weeksto17monthsinkilifikenyaacrosssectionalobservationalstudy |