National Blood Pressure Screening in Children to Improve Paediatric Healthcare in South Africa
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-18
SponsorNorth-West University, South Africa
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
All children between ages 5-<18 years
All children with voluntary assent/consent and parent's permission
Disqualifiers
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
Trial population
The target population for this study includes 5 to under 18 years school-aged children in South Africa from all provinces in the country selected in a randomized manner and to ensure generalizability. All South African public ordinary schools are categorised into five groups, called quintiles, largely for purposes of the allocation of financial resources from government. Quintile one is the lowest socioeconomic quintile, while quintile five is the highest. In addition, lower quintile schools are mostly rural and/or peri-urban. Participants will be drawn from quintile 1-5 schools and those in more remote areas will be reached via mobile fieldwork teams. 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 and rural settings in all provinces.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Blood pressure screening
Diagnostic testBlood 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.
Treatment groups
22,464 Participants
are divided into 2 treatment groupsGroup A: Boys1 intervention
Group B: Girls1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Through study completion, an average of 1 year2
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.
Time frame
Through study completion, an average of 1 year3
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.
Time frame
Through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
North-West University, South Africa
Lead sponsor
Medical Research Council, South Africa
Collaborator
University of Cape Town
Collaborator
University of Limpopo
Collaborator
Walter Sisulu University
Collaborator
University of KwaZulu
Collaborator
Red Cross War Memorial Childrens Hospital
Collaborator
University of Witwatersrand, South Africa
Collaborator
University of Zurich
Collaborator
Groote Schuur Hospital
Collaborator
Nelson Mandela Metropolitan University
Collaborator
Chris Hani Baragwanath Academic Hospital
Collaborator
University of the Free State
Collaborator
Source ClinicalTrials.gov