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

  • NCT ID: NCT05982847
  • Time Stamp: January 31, 2024
  • Source Node: 84008
  • Name: Lebo F Gafane-Matemane, PhD
  • Email: lebo.gafane@nwu.ac.za
  • Phone: +27182992193
  • 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.

Studies

Study First Submitted Date 2023-08-01
Study First Posted Date 2023-08-09
Last Update Posted Date 2023-08-09
Start Month Year February 1, 2024
Primary Completion Month Year November 30, 2028
Verification Month Year August 2023
Verification Date 2023-08-31
Last Update Posted Date 2023-08-09

Detailed Descriptions

Sequence: 20791726
Description Rationale: Currently there exist no nationally representative set of normative reference values for blood pressure and anthropometry in South African children, while we 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: We 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: We expect that normative blood pressure in children (ages above 5 and under 18 years) will differ from currently accepted international thresholds. We 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. We will also develop the first clinical practice guidelines for the management of hypertension in children in South Africa in collaboration with hypertension societies.

Facilities

Sequence: 200694026 Sequence: 200694027 Sequence: 200694028 Sequence: 200694029 Sequence: 200694030 Sequence: 200694031 Sequence: 200694032 Sequence: 200694033 Sequence: 200694034 Sequence: 200694035 Sequence: 200694036
Name Walter Sisulu University Name Nelson Mandela Metropolitan University Name University of the Free State Name University of the Witwatersrand Name University of KwaZulu-Natal Name University of Limpopo Name Hypertension in Africa Research Team (HART), North-West University Name Red Cross War Memorial Children Hospital Name South African Medical Research Council Name University of Cape Town Name University of Zurich
City Mthatha City Port Elizabeth City Bloemfontein City Johannesburg City Durban City Polokwane City Potchefstroom City Cape Town City Cape Town City Cape Town City Zürich
State Eastern Cape State Eastern Cape State Free State State Gauteng State KwaZulu-Natal State Limpopo State North West State Western Cape State Western Cape State Western Cape
Zip 2531
Country South Africa Country South Africa Country South Africa Country South Africa Country South Africa Country South Africa Country South Africa Country South Africa Country South Africa Country South Africa Country Switzerland

Facility Contacts

Sequence: 28199204 Sequence: 28199205 Sequence: 28199206 Sequence: 28199207 Sequence: 28199208 Sequence: 28199209 Sequence: 28199210 Sequence: 28199211 Sequence: 28199212 Sequence: 28199213 Sequence: 28199214 Sequence: 28199215 Sequence: 28199216 Sequence: 28199217 Sequence: 28199218 Sequence: 28199219
Facility Id 200694026 Facility Id 200694027 Facility Id 200694027 Facility Id 200694028 Facility Id 200694029 Facility Id 200694029 Facility Id 200694030 Facility Id 200694031 Facility Id 200694032 Facility Id 200694033 Facility Id 200694033 Facility Id 200694034 Facility Id 200694034 Facility Id 200694035 Facility Id 200694035 Facility Id 200694036
Contact Type primary Contact Type primary Contact Type backup Contact Type primary Contact Type primary Contact Type backup Contact Type primary Contact Type primary Contact Type primary Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary Contact Type backup Contact Type primary
Name Benedicta Nkeh-Chungag, PhD Name Aayesha Kholvadia, PhD Name Cheryl Walter, PhD Name Johannes Cronje, MD Name Shane Norris, PhD Name Lisa J Ware, PhD Name Rajendra Bhimma, MD Name Kotsedi D Monyeki, PhD Name Ruan Kruger, PhD Name Peter Nourse, MD Name Mignon McCulloch, MD Name Liesl Zuhlke, MD Name Rabia Johnson, PhD Name Sandra Mukasa, PhD Name Erika Jones, MD Name Friedrich Thienemann, MD
Email bnkehchungag@wsu.ac.za Email Aayesha.Kholvadia@mandela.ac.za Email cheryl.walter@mandela.ac.za Email rigel.jcc@gmail.com Email shane.norris@wits.ac.za Email lisa.ware@wits.ac.za Email bhimma@ukzn.ac.za Email kotsedi.monyeki@ul.ac.za Email Ruan.Kruger@nwu.ac.za Email peter.nourse@uct.ac.za Email mignon.mcculloch@uct.ac.za Email liesl.zuhlke@mrc.ac.za Email rabia.johnson@mrc.ac.za Email sandra.mukasa@uct.ac.za Email erika.jones@uct.ac.za Email friedrich.thienemann@uct.ac.za
Phone +27475021989 Phone +27824902342
Phone Extension 992904

Facility Investigators

Sequence: 18387825 Sequence: 18387826 Sequence: 18387827 Sequence: 18387828 Sequence: 18387829 Sequence: 18387830 Sequence: 18387831 Sequence: 18387832 Sequence: 18387833 Sequence: 18387834 Sequence: 18387835 Sequence: 18387836
Facility Id 200694029 Facility Id 200694029 Facility Id 200694029 Facility Id 200694029 Facility Id 200694029 Facility Id 200694029 Facility Id 200694029 Facility Id 200694032 Facility Id 200694034 Facility Id 200694035 Facility Id 200694035 Facility Id 200694036
Role Sub-Investigator Role Sub-Investigator Role Sub-Investigator Role Sub-Investigator Role Sub-Investigator Role Sub-Investigator Role Sub-Investigator Role Sub-Investigator Role Sub-Investigator Role Sub-Investigator Role Sub-Investigator Role Sub-Investigator
Name Bhavisha Nagar, MD Name Karen Peterson, MD Name Innocent Maposa, PhD Name Sanushka Naidoo, MD Name Stephen Tollman, MD Name Xavier Gómez-Olivé, MD Name Nilesh Lala, MD Name Lebo F Gafane-Matemane, PhD Name Jyoti Sharma, PhD Name Friedrich Thienemann, MD Name Landon Myer, MD Name Patrick Katoto, PhD

Conditions

Sequence: 52350420 Sequence: 52350421 Sequence: 52350422
Name Hypertension Name Obesity, Adolescent Name Obesity, Childhood
Downcase Name hypertension Downcase Name obesity, adolescent Downcase Name obesity, childhood

Id Information

Sequence: 40287075
Id Source org_study_id
Id Value REC 4/23/03/22

Countries

Sequence: 42708574 Sequence: 42708575
Name South Africa Name Switzerland
Removed False Removed False

Design Groups

Sequence: 55793435 Sequence: 55793436
Title Boys Title Girls

Interventions

Sequence: 52661751
Intervention Type Diagnostic Test
Name Blood pressure screening
Description 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.

Keywords

Sequence: 80116519 Sequence: 80116520 Sequence: 80116521 Sequence: 80116522 Sequence: 80116523
Name Adiposity Name Blood Pressure Name Cardiovascular Diseases Name Health Knowledge, Attitudes, Practice Name Lifestyle Factors
Downcase Name adiposity Downcase Name blood pressure Downcase Name cardiovascular diseases Downcase Name health knowledge, attitudes, practice Downcase Name lifestyle factors

Design Outcomes

Sequence: 178041864 Sequence: 178041865 Sequence: 178041866
Outcome Type primary Outcome Type primary Outcome Type primary
Measure To determine and compute nationally representative normative reference values for blood pressure in children Measure To determine and compute nationally representative normative reference values for blood pressure in children Measure To develop clinical practice guidelines for the management of childhood hypertension in South Africa
Time Frame Through study completion, an average of 1 year Time Frame Through study completion, an average of 1 year Time Frame Through study completion, an average of 1 year
Description 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. Description 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. Description 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.

Browse Conditions

Sequence: 194170220 Sequence: 194170221 Sequence: 194170222 Sequence: 194170223 Sequence: 194170224 Sequence: 194170225 Sequence: 194170226 Sequence: 194170227 Sequence: 194170228
Mesh Term Hypertension Mesh Term Obesity Mesh Term Pediatric Obesity Mesh Term Overweight Mesh Term Overnutrition Mesh Term Nutrition Disorders Mesh Term Body Weight Mesh Term Vascular Diseases Mesh Term Cardiovascular Diseases
Downcase Mesh Term hypertension Downcase Mesh Term obesity Downcase Mesh Term pediatric obesity Downcase Mesh Term overweight Downcase Mesh Term overnutrition Downcase Mesh Term nutrition disorders Downcase Mesh Term body weight Downcase Mesh Term vascular diseases Downcase Mesh Term cardiovascular diseases
Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48486989 Sequence: 48486990 Sequence: 48486991 Sequence: 48486992 Sequence: 48486993 Sequence: 48486994 Sequence: 48486995 Sequence: 48486996 Sequence: 48486997 Sequence: 48486998 Sequence: 48486999 Sequence: 48487000 Sequence: 48487001
Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class UNKNOWN Agency Class OTHER Agency Class OTHER Agency Class UNKNOWN
Lead Or Collaborator lead Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator
Name North-West University, South Africa Name Medical Research Council, South Africa Name University of Cape Town Name University of Limpopo Name Walter Sisulu University Name University of KwaZulu Name Red Cross War Memorial Childrens Hospital Name University of Witwatersrand, South Africa Name University of Zurich Name Groote Schuur Hospital Name Nelson Mandela Metropolitan University Name Chris Hani Baragwanath Academic Hospital Name University of the Free State

Central Contacts

Sequence: 12054063 Sequence: 12054064
Contact Type primary Contact Type backup
Name Ruan Kruger, PhD Name Lebo F Gafane-Matemane, PhD
Phone +27182992904 Phone +27182992193
Email ruan.kruger@nwu.ac.za Email lebo.gafane@nwu.ac.za
Role Contact Role Contact

Design Group Interventions

Sequence: 68393307 Sequence: 68393308
Design Group Id 55793435 Design Group Id 55793436
Intervention Id 52661751 Intervention Id 52661751

Eligibilities

Sequence: 30869299
Sampling Method Probability Sample
Gender All
Minimum Age 5 Years
Maximum Age 18 Years
Healthy Volunteers Accepts Healthy Volunteers
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.
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.
Adult True
Child True
Older Adult False

Calculated Values

Sequence: 254022060
Number Of Facilities 11
Registered In Calendar Year 2023
Were Results Reported False
Has Us Facility False
Has Single Facility False
Minimum Age Num 5
Maximum Age Num 18
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 3

Designs

Sequence: 30615106
Observational Model Cohort
Time Perspective Prospective

Intervention Other Names

Sequence: 26758681
Intervention Id 52661751
Name Anthropometric measurements

Links

Sequence: 4402092
Url https://www.chc-sa.org/home
Description CHCSA website

Responsible Parties

Sequence: 28981634
Responsible Party Type Principal Investigator
Name Ruan Kruger
Title Professor
Affiliation North-West University, South Africa
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