Clinical trial

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

Recruiting now · Not applicable · 2 countries · Registry ID NCT05982847

Recruiting nowNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age5 Years to 18 Years

SexAll

Healthy volunteersAccepted

ConditionHypertension, Obesity, Adolescent, Obesity, Childhood

Full registry 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.

Treatments and study arms

Blood pressure screening

Diagnostic Test

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.

Primary outcomes

To determine and compute nationally representative normative reference values for blood pressure in childrenThrough study completion, an average of 1 year

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.

To determine and compute nationally representative normative reference values for blood pressure in childrenThrough study completion, an average of 1 year

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.

To develop clinical practice guidelines for the management of childhood hypertension in South AfricaThrough study completion, an average of 1 year

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.