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

March 19, 2024 updated by: Ruan Kruger, North-West University, South Africa

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

22464

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • South Africa
    • Eastern Cape
      • Mthatha, Eastern Cape, South Africa
        • Not yet recruiting
        • Walter Sisulu University
        • Contact:
      • Port Elizabeth, Eastern Cape, South Africa
    • Free State
      • Bloemfontein, Free State, South Africa
        • Recruiting
        • University of the Free State
        • Contact:
    • Gauteng
      • Johannesburg, Gauteng, South Africa
        • Not yet recruiting
        • University of the Witwatersrand
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Bhavisha Nagar, MD
        • Sub-Investigator:
          • Karen Peterson, MD
        • Sub-Investigator:
          • Innocent Maposa, PhD
        • Sub-Investigator:
          • Sanushka Naidoo, MD
        • Sub-Investigator:
          • Stephen Tollman, MD
        • Sub-Investigator:
          • Xavier Gómez-Olivé, MD
        • Sub-Investigator:
          • Nilesh Lala, MD
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa
        • Not yet recruiting
        • University of KwaZulu-Natal
        • Contact:
    • Limpopo
      • Polokwane, Limpopo, South Africa
    • North West
      • Potchefstroom, North West, South Africa, 2531
        • Recruiting
        • Hypertension in Africa Research Team (HART), North-West University
        • Contact:
        • Sub-Investigator:
          • Lebo F Gafane-Matemane, PhD
    • Western Cape
      • Cape Town, Western Cape, South Africa
      • Cape Town, Western Cape, South Africa
      • Cape Town, Western Cape, South Africa
        • Not yet recruiting
        • University of Cape Town
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Friedrich Thienemann, MD
        • Sub-Investigator:
          • Landon Myer, MD
        • Sub-Investigator:
          • Patrick Katoto, PhD
  • Switzerland
      • Zürich, Switzerland
        • Not yet recruiting
        • University of Zurich
        • Sub-Investigator:
          • Friedrich Thienemann, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Boys
Diagnostic test: Blood 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.
Other Names:
  • Anthropometric measurements
Girls
Diagnostic test: Blood 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.
Other Names:
  • Anthropometric measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine and compute nationally representative normative reference values for blood pressure in children
Time Frame: Through study completion, an average of 1 year
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
Time Frame: Through study completion, an average of 1 year
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
Time Frame: Through study completion, an average of 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North-West University, South Africa

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

November 30, 2028

Study Registration Dates

First Submitted

August 1, 2023

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 9, 2023

Study Record Updates

Last Update Posted (Actual)

March 20, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC 4/23/03/22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The national data will be first collated to develop the nomograms for blood pressure and anthropometric measurements. The data will be made available upon reasonable request from the principal investigator(s) after publication of the nomograms findings.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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