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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hypertension, Obesity, Adolescent, Obesity, Childhood

Intervention / Treatment
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* Diagnostic Test: Blood pressure screening


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Boys<br> | Diagnostic Test: Blood pressure screening<br>* 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.<br>* Other names: Anthropometric measurements;|
| Girls<br> | Diagnostic Test: Blood pressure screening<br>* 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.<br>* Other names: Anthropometric measurements;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adiposity, Blood Pressure, Cardiovascular Diseases, Health Knowledge, Attitudes, Practice, Lifestyle Factors