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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05982847
• Other study ID #: REC 4/23/03/22
• Status: Recruiting
• Start date: April 1, 2024
• Est. completion date: November 30, 2028

Study information

• Verified date: March 2024
• Source: North-West University, South Africa
• Contact: Ruan Kruger, PhD
• Phone: +27182992904
• Email: ruan.kruger[@]nwu.ac.za
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22464
• Est. completion date: November 30, 2028
• Est. primary completion date: November 30, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Obesity
• Obesity, Adolescent
• Obesity, Childhood
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
South Africa	University of the Free State	Bloemfontein	Free State
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 KwaZulu-Natal	Durban	KwaZulu-Natal
South Africa	University of the Witwatersrand	Johannesburg	Gauteng
South Africa	Walter Sisulu University	Mthatha	Eastern Cape
South Africa	University of Limpopo	Polokwane	Limpopo
South Africa	Nelson Mandela Metropolitan University	Port Elizabeth	Eastern Cape
South Africa	Hypertension in Africa Research Team (HART), North-West University	Potchefstroom	North West
Switzerland	University of Zurich	Zürich

Sponsors (13)

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

Countries where clinical trial is conducted

South Africa,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine and compute nationally representative normative reference values for blood pressure in children	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
Primary	To determine and compute nationally representative normative reference values for blood pressure in children	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
Primary	To develop clinical practice guidelines for the management of childhood hypertension in South Africa	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

External Links

•   CHCSA website