National Blood Pressure Screening in Children to Improve Paediatric Healthcare in South Africa
NCT ID: NCT05982847
Last Updated: 2024-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
22464 participants
OBSERVATIONAL
2024-04-01
2028-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Boys
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.
Girls
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* All children with voluntary assent/consent and parent's permission
Exclusion Criteria
* 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.
5 Years
18 Years
ALL
Yes
Sponsors
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Medical Research Council, South Africa
OTHER
University of Cape Town
OTHER
University of Limpopo
OTHER
Walter Sisulu University
OTHER
University of KwaZulu
OTHER
Red Cross War Memorial Childrens Hospital
OTHER
University of Witwatersrand, South Africa
OTHER
University of Zurich
OTHER
Groote Schuur Hospital
UNKNOWN
Nelson Mandela Metropolitan University
OTHER
Chris Hani Baragwanath Academic Hospital
OTHER
University of the Free State
UNKNOWN
North-West University, South Africa
OTHER
Responsible Party
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Ruan Kruger
Professor
Locations
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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, 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
Countries
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Central Contacts
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Facility Contacts
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Related Links
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CHCSA website
Other Identifiers
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REC 4/23/03/22
Identifier Type: -
Identifier Source: org_study_id
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