Primary Prevention of Stroke in Children With Sickle Cell Anaemia in Nigeria in the Community
SPRING-COM
1 other identifier
interventional
217
1 country
1
Brief Summary
The overall goal of this feasibility study is to establish a standard of care stroke prevention program for children with sickle cell anemia in a community hospital by task shifting stroke detection and transcranial Doppler ultrasound screening to nurses. In Nigeria, approximately 150,000 children with sickle cell anemia (SCA) are born annually, accounting for more than half of the total births with SCA worldwide. In comparison, only 1,700 children with SCA are born in the United States annually. An estimated 11% of unscreened and untreated children at increase of strokes with SCA will have at least one stroke by 17 years of age. In high-income countries, evidence-based practices (EBP) for primary stroke prevention in children with SCA involves screening for abnormal transcranial Doppler ultrasound (TCD) velocity (\>200cm/s) coupled with regular blood transfusion therapy for at least one year followed by treatment with hydroxyurea is considered standard care. This strategy decreases the risk of stroke by 92%. Due to safety and availability, regular blood transfusion is not a viable option for primary stroke prevention in most low-income settings, including Nigeria, where \~50% of the 300,000 children with SCA are born. Among each birth cohort, 15,000 children will have stroke annually in Nigeria. The American Society of Hematology (ASH) Central Nervous System Guidelines recommends moderate dose hydroxyurea (20mg/kg) to children with SCA with abnormal TCD measurements, living in resource-constrained settings where regular blood transfusions are not readily available. Our team has demonstrated in a previous trial the feasibility of primary stroke prevention with hydroxyurea in Kano, Nigeria. In 2016, as part of capacity building objective of Stroke Prevention Trial in Nigeria (1R01NS094041-SPRING) at Barau Dikko Teaching Hospital in Kaduna, TCD screening was adopted as standard of care. Before the trial, no TCD screening was done at our trial site in Kaduna. Now, as standard care, physicians at the teaching hospital do TCD screening, however, only 5.4% (1,101/20,040) of the eligible children with SCA living in Kaduna, Nigeria were reached. Clearly, for there to be an appreciable impact on decreasing the stroke rates in children with SCA living in Nigeria and elsewhere, applying the ASH guidelines and a better implementation strategy to increase the TCD reach (proportion of children eligible for TCD screening that are screened) is necessary. Therefore, objective of this physician-mentored application is to conduct an Effectiveness-Implementation Feasibility Trial is to test the test the hypothesis that the task-shifted site for primary stroke prevention team in a community hospital will have a non-inferior effectiveness in identifying children with abnormal TCD measurements when compared to primary stroke prevention team in a teaching hospital in Kaduna, Nigeria. the investigators will conduct i) a needs assessment at the community hospital to identify barriers and facilitators to the intervention, ii) Build capacity for stroke detection and TCD screening and iii) Compare the effectiveness of a physician-based stroke prevention program in a teaching hospital to a task-shifted stroke prevention in a community hospital.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 6, 2021
CompletedFirst Submitted
Initial submission to the registry
June 19, 2022
CompletedFirst Posted
Study publicly available on registry
June 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2025
CompletedAugust 1, 2023
July 1, 2023
4.6 years
June 19, 2022
July 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Reach
The portion of children than received TCD screening at least once in the community hospital
1 year
Effectiveness
The proportion of children with abnormal TCD measurement started on hydroxyurea
1 year
Secondary Outcomes (3)
Stroke occurrence
1 year
Clinical events among children on Hydroxyurea
1 year
Clinical events among children not on Hydroxyurea
1 year
Study Arms (1)
Children with sickle cell anaemia and abnormal TCD values (200cm/s)
OTHERThe children identified with abnormal TCD values will be given hydroxyurea and followed for one year
Interventions
Children at risk of developing stroke (TCD values\>200cm/s) will be given 20mg/kg of Hydroxyurea
Eligibility Criteria
You may qualify if:
- Children with diagnosis of SCA (HbSS or HbSβthal0)
- years receiving care at both YDMH (community hospital) and BDTH (teaching hospital).
- No previous stroke
You may not qualify if:
- Children with SCA younger than 2 years or older than 16
- Children with stroke
- \) Children already on Hydroxyurea
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Barau Dikko Teaching Hospital/Kaduna State University
Kaduna, Nigeria
Related Publications (2)
Bello-Manga H, Haliru L, Ahmed K, Ige S, Musa H, Muhammad-Idris ZK, Monday B, Sani AM, Bonnet K, Schlundt DG, Varughese T, Tabari AM, DeBaun MR, Baumann AA, King AA. Barriers and facilitators to a task-shifted stroke prevention program for children with sickle cell anemia in a community hospital: a qualitative study. Implement Sci Commun. 2024 Jan 15;5(1):10. doi: 10.1186/s43058-023-00534-z.
PMID: 38225633DERIVEDBello-Manga H, Haliru L, Ahmed K, Ige S, Musa H, Muhammad-Idris ZK, Monday B, Sani AM, Bonnet K, Schlundt DG, Varughese T, Tabari AM, DeBaun MR, Baumann AA, King AA. Barriers and Facilitators to a Task-Shifted Stroke Prevention Program for Children with Sickle Cell Anemia in a Community Hospital: A Qualitative Study. Res Sq [Preprint]. 2023 Jul 3:rs.3.rs-2985921. doi: 10.21203/rs.3.rs-2985921/v1.
PMID: 37461538DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Halima Bello-Manga, MBBS,MPH
Barau Dikko Teaching Hospital/Kaduna State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2022
First Posted
June 27, 2022
Study Start
January 6, 2021
Primary Completion
July 31, 2025
Study Completion
July 31, 2025
Last Updated
August 1, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- When study is completed
- Access Criteria
- Access will be granted with permission
The audiences most suitable for these results are persons affected with SCD and their families, health care providers, administrators, policy makers and other researchers in both SCD and implementation science. We believe dissemination of the results from this study will have immediate public health impact. The results will be published in high-impact journals like the New England Journal of Medicine, Lancet, Blood, American Journal of Hematology as well as presentations at National and International Scientific Conferences. The stakeholders in the community and teaching hospitals, and the State ministry of health will be provided with annual updates on study progress and interim results. We will also present study progress to the during the annual World Sickle Cell Day celebration, usually organized by community-based SCD support groups.