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National Blood Pressure Screening in Children to Improve Paediatric Healthcare in South Africa

National Blood Pressure Screening in Children to Optimise Clinical Management of Paediatric Hypertension in South Africa

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05982847
Enrollment
22464
Registered
2023-08-09
Start date
2024-04-01
Completion date
2028-11-30
Last updated
2026-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Obesity, Adolescent, Obesity, Childhood

Keywords

Adiposity, Blood Pressure, Cardiovascular Diseases, Health Knowledge, Attitudes, Practice, Lifestyle Factors

Brief 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.

Detailed 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.

Interventions

DIAGNOSTIC_TESTBlood pressure screening

Blood pressure and anthropometric measurements will be performed in children and adolescents between ages 5-18 years to develop South African nomograms that will aid in the development of clinical practice guidelines to optimise hypertension care in South Africa youth.

Sponsors

North-West University, South Africa
Lead SponsorOTHER
Medical Research Council, South Africa
CollaboratorOTHER
University of Cape Town
CollaboratorOTHER
University of Limpopo
CollaboratorOTHER
Walter Sisulu University
CollaboratorOTHER
University of KwaZulu
CollaboratorOTHER
Red Cross War Memorial Childrens Hospital
CollaboratorOTHER
University of Witwatersrand, South Africa
CollaboratorOTHER
University of Zurich
CollaboratorOTHER
Groote Schuur Hospital
CollaboratorUNKNOWN
Nelson Mandela Metropolitan University
CollaboratorOTHER
Chris Hani Baragwanath Academic Hospital
CollaboratorOTHER
University of the Free State
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* All children between ages 5-\<18 years * All children with voluntary assent/consent and parent's permission

Exclusion criteria

* circumstances interfere with the participant's ability to give informed consent (diminished understanding or comprehension, or any language barriers that may pose potential risk in participation under false expectations) * randomly selected children who choose not to participate (lack of assent/consent), even if parent's permission was received, * conditions that interfere with a patient's ability to follow study guidelines, e.g., the use of drugs, alcohol or tobacco products * ages \>18 years or under 5 years * Children will be excluded from the analysis for the determination of normative reference values for blood pressure and anthropometry if taking certain concomitant medication(s) that may affect their blood pressure, or any underlying disease e.g., chronic kidney disease, chronic heart disease etc. that may raise blood pressure.

Design outcomes

Primary

MeasureTime frameDescription
To determine and compute nationally representative normative reference values for blood pressure in childrenThrough study completion, an average of 1 yearTo date there are no national normative blood pressure reference values for children in South Africa. Normative values used by clinicians are those extrapolated from studies on blood pressure done in the USA and Europe and these may not be truly representative of normative values of blood pressure in South Africa. This study aims to address this issue, because children can be misdiagnosed for high blood pressure based on the wrong normative values.
To develop clinical practice guidelines for the management of childhood hypertension in South AfricaThrough study completion, an average of 1 yearThe findings of this study will help develop clinically relevant guidelines for the management of hypertension in children between 5 and 18 years of age based on local normative values, as well as to improve cost and availability of anti-hypertensive agents for children and adolescents.

Countries

South Africa, Switzerland

Contacts

CONTACTRuan Kruger, PhD
ruan.kruger@nwu.ac.za+27182992904
CONTACTLebo F Gafane-Matemane, PhD
lebo.gafane@nwu.ac.za+27182992193

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 8, 2026