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Clinical Trial Summary

The Childhood Hypertension Consortium of South Africa (CHCSA) was established to foster relationships between the healthcare sector and schools through community engagement and outreach as well as contributing to the decolonization of normative paediatric blood pressure reference values. To date, there has been no nation-wide project in South Africa to determine nationally representative normal blood pressure reference values, nor to estimate the true prevalence of hypertension in the paediatric population of the country. This study will provide critical information on the understanding of blood pressure and hypertension in children, especially of African ancestry. Not only will this effort contribute to the development of the first nationally representative normal reference values of blood pressure but will also benefit healthcare providers in the sector with a clear guideline on the management of high blood pressure in children as developed by experts working with these challenges daily.


Clinical Trial Description

Rationale: Currently there exist no nationally representative set of normative reference values for blood pressure and anthropometry in South African children, while clinicians rely on European and US reference values. The latter seems inappropriate in the South African setting, especially considering the lack of data available in African ancestry normative data. Objectives: The investigators aim to development the first nationally representative normal reference values of blood pressure and anthropometry in children, to develop scientific evidence-based hypertension guidelines in the paediatric population of South Africa. Methods: The target population for this study includes 5 to under 18 years school-aged (all school quintiles) children in South Africa from all provinces in the country selected in a randomized manner and to ensure generalizability. Population: A sample of 22 464 (81% Black African; 9% Coloured; 8% White and 2% Indian/Asian) will be required to enable computation of reference values for each age and sex across urban, peri-urban and rural settings in all provinces. Time frame: The study will recruit and collect data over a period of five years. Expected outcomes: The investigators expect that normative blood pressure in children (ages above 5 and under 18 years) will differ from currently accepted international thresholds. The investigators will engage in the communities to optimise awareness and care of high blood pressure and its comorbidities. Recommendations will be made to the National Department of Health regarding blood pressure measurement/screening for hypertension in children at the local clinic in the Road to Health booklet. The investigators will also develop the first clinical practice guidelines for the management of hypertension in children in South Africa in collaboration with hypertension societies. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05982847
Study type Observational
Source North-West University, South Africa
Contact Ruan Kruger, PhD
Phone +27182992904
Email ruan.kruger@nwu.ac.za
Status Recruiting
Phase
Start date April 1, 2024
Completion date November 30, 2028

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