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

Last updated: September 4, 2024
Sponsor: North-West University, South Africa
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vascular Diseases

Obesity

Circulation Disorders

Treatment

Blood pressure screening

Clinical Study ID

NCT05982847
REC 4/23/03/22
  • Ages 5-18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All children between ages 5-<18 years

  • All children with voluntary assent/consent and parent's permission

Exclusion

Exclusion Criteria:

  • circumstances interfere with the participant's ability to give informed consent (diminished understanding or comprehension, or any language barriers that may posepotential 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 normativereference values for blood pressure and anthropometry if taking certain concomitantmedication(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 Design

Total Participants: 22464
Treatment Group(s): 1
Primary Treatment: Blood pressure screening
Phase:
Study Start date:
April 01, 2024
Estimated Completion Date:
November 30, 2028

Study 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.

Connect with a study center

  • Walter Sisulu University

    Mthatha, Eastern Cape
    South Africa

    Site Not Available

  • Nelson Mandela Metropolitan University

    Port Elizabeth, Eastern Cape
    South Africa

    Site Not Available

  • University of the Free State

    Bloemfontein, Free State
    South Africa

    Site Not Available

  • University of the Witwatersrand

    Johannesburg, Gauteng
    South Africa

    Site Not Available

  • University of KwaZulu-Natal

    Durban, KwaZulu-Natal
    South Africa

    Site Not Available

  • University of Limpopo

    Polokwane, Limpopo
    South Africa

    Site Not Available

  • Hypertension in Africa Research Team (HART), North-West University

    Potchefstroom, North West 2531
    South Africa

    Site Not Available

  • Red Cross War Memorial Children Hospital

    Cape Town, Western Cape
    South Africa

    Site Not Available

  • South African Medical Research Council

    Cape Town, Western Cape
    South Africa

    Site Not Available

  • University of Cape Town

    Cape Town, Western Cape
    South Africa

    Site Not Available

  • University of Zurich

    Zürich,
    Switzerland

    Site Not Available

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