National blood pressure screening for children in South Africa
National Blood Pressure Screening in Children to Optimise Clinical Management of Paediatric Hypertension in South Africa
This study is trying to find out what normal blood pressure levels are for children in South Africa so that doctors can better manage high blood pressure in kids, especially those of African descent.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 22464 (estimated) |
| Ages | 5 Years to 18 Years |
| Sex | All |
| Sponsor | North-West University, South Africa Academic / other |
| Locations | 11 sites (Mthatha, Eastern Cape and 10 other locations) |
| Trial ID | NCT05982847 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish nationally representative blood pressure reference values for children aged 5 to under 18 years in South Africa. By engaging with schools and communities, the study will collect data from a diverse sample of over 22,000 children across various regions. The goal is to develop evidence-based guidelines for managing hypertension in the pediatric population, particularly for those of African ancestry, addressing the current reliance on inappropriate international standards.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 5 to under 18 years from diverse backgrounds in South Africa.
Not a fit: Patients over 18 years or under 5 years, as well as those with conditions affecting blood pressure or unable to provide consent, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved hypertension management and health outcomes for children in South Africa.
How similar studies have performed: While there have been studies on hypertension in children, this approach to establish localized reference values is novel and has not been previously conducted on a national scale in South Africa.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Mthatha, Eastern Cape and 10 other locations
- Walter Sisulu University — Mthatha, Eastern Cape, South Africa (Not_yet_recruiting)
- Nelson Mandela Metropolitan University — Port Elizabeth, Eastern Cape, South Africa (Recruiting)
- University of the Free State — Bloemfontein, Free State, South Africa (Recruiting)
- University of the Witwatersrand — Johannesburg, Gauteng, South Africa (Recruiting)
- University of KwaZulu-Natal — Durban, KwaZulu-Natal, South Africa (Not_yet_recruiting)
- University of Limpopo — Polokwane, Limpopo, South Africa (Not_yet_recruiting)
- Hypertension in Africa Research Team (HART), North-West University — Potchefstroom, North West, South Africa (Recruiting)
- Red Cross War Memorial Children Hospital — Cape Town, Western Cape, South Africa (Not_yet_recruiting)
- South African Medical Research Council — Cape Town, Western Cape, South Africa (Not_yet_recruiting)
- University of Cape Town — Cape Town, Western Cape, South Africa (Not_yet_recruiting)
- University of Zurich — Zurich, Switzerland (Not_yet_recruiting)
Study contacts
- Study coordinator: Ruan Kruger, PhD
- Email: ruan.kruger@nwu.ac.za
- Phone: +27182992904
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.