RecruitingNot Applicable

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

South Africa, Switzerland22,464 participantsStarted 2024-04-01

Plain-language 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.

Who can participate

Age range

5 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To determine and compute nationally representative normative reference values for blood pressure in children

Timeframe: Through study completion, an average of 1 year

To determine and compute nationally representative normative reference values for blood pressure in children

Timeframe: Through study completion, an average of 1 year

To develop clinical practice guidelines for the management of childhood hypertension in South Africa

Timeframe: Through study completion, an average of 1 year

Trial details

NCT IDNCT05982847

SponsorNorth-West University, South Africa

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-11-30

Contact for this trial

Ruan Kruger, PhD

+27182992904 ruan.kruger@nwu.ac.za

View on ClinicalTrials.gov More Hypertension trials

Plain-language summary

Who can participate

Age range

5 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

To determine and compute nationally representative normative reference values for blood pressure in children

Timeframe: Through study completion, an average of 1 year

To determine and compute nationally representative normative reference values for blood pressure in children

Timeframe: Through study completion, an average of 1 year

To develop clinical practice guidelines for the management of childhood hypertension in South Africa

Timeframe: Through study completion, an average of 1 year