National Blood Pressure Screening in Children to Improve Paediatric Healthcare in South Africa
1 other identifier
observational
22,464
2 countries
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2024
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2023
CompletedFirst Posted
Study publicly available on registry
August 9, 2023
CompletedStudy Start
First participant enrolled
April 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2028
September 5, 2024
September 1, 2024
4.7 years
August 1, 2023
September 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
To determine and compute nationally representative normative reference values for blood pressure in children
To 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.
Through study completion, an average of 1 year
To determine and compute nationally representative normative reference values for blood pressure in children
Overweight and obesity classification according to the World Health Organisation percentiles for childhood obesity only include a small sample size from less than five African countries, therefore the underrepresentation of children of African ancestry will be addressed by this study.
Through study completion, an average of 1 year
To develop clinical practice guidelines for the management of childhood hypertension in South Africa
The 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.
Through study completion, an average of 1 year
Study Arms (2)
Boys
Girls
Interventions
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.
Eligibility Criteria
The target population for this study includes 5 to under 18 years school-aged children in South Africa from all provinces in the country selected in a randomized manner and to ensure generalizability. All South African public ordinary schools are categorised into five groups, called quintiles, largely for purposes of the allocation of financial resources from government. Quintile one is the lowest socioeconomic quintile, while quintile five is the highest. In addition, lower quintile schools are mostly rural and/or peri-urban. Participants will be drawn from quintile 1-5 schools and those in more remote areas will be reached via mobile fieldwork teams. 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 and rural settings in all provinces.
You may qualify if:
- All children between ages 5-\<18 years
- All children with voluntary assent/consent and parent's permission
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- North-West University, South Africalead
- Medical Research Council, South Africacollaborator
- University of Cape Towncollaborator
- University of Limpopocollaborator
- Walter Sisulu Universitycollaborator
- University of KwaZulucollaborator
- Red Cross War Memorial Childrens Hospitalcollaborator
- University of Witwatersrand, South Africacollaborator
- University of Zurichcollaborator
- Groote Schuur Hospitalcollaborator
- Nelson Mandela Metropolitan Universitycollaborator
- Chris Hani Baragwanath Academic Hospitalcollaborator
- University of the Free Statecollaborator
Study Sites (11)
Walter Sisulu University
Mthatha, Eastern Cape, South Africa
Nelson Mandela Metropolitan University
Port Elizabeth, Eastern Cape, South Africa
University of the Free State
Bloemfontein, Free State, South Africa
University of the Witwatersrand
Johannesburg, Gauteng, South Africa
University of KwaZulu-Natal
Durban, KwaZulu-Natal, South Africa
University of Limpopo
Polokwane, Limpopo, South Africa
Hypertension in Africa Research Team (HART), North-West University
Potchefstroom, North West, 2531, South Africa
Red Cross War Memorial Children Hospital
Cape Town, Western Cape, South Africa
South African Medical Research Council
Cape Town, Western Cape, South Africa
University of Cape Town
Cape Town, Western Cape, South Africa
University of Zurich
Zurich, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 1, 2023
First Posted
August 9, 2023
Study Start
April 1, 2024
Primary Completion (Estimated)
November 30, 2028
Study Completion (Estimated)
November 30, 2028
Last Updated
September 5, 2024
Record last verified: 2024-09