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Primary Prevention of Stroke in Children With Sickle Cell Anaemia in Nigeria in the Community (SPRING-COM)

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ClinicalTrials.gov Identifier: NCT05434000
Recruitment Status : Recruiting
First Posted : June 27, 2022
Last Update Posted : June 27, 2022
Information provided by (Responsible Party):
Barau Dikko Teaching Hospital

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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Stroke Drug: Hydroxyurea Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 217 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Primary Prevention of Stroke in Children With Sickle Cell Anaemia in Nigeria: Community vs Teaching Hospital
Actual Study Start Date : November 6, 2021
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia
Drug Information available for: Hydroxyurea

Arm Intervention/treatment
Children with sickle cell anaemia and abnormal TCD values (200cm/s)
The children identified with abnormal TCD values will be given hydroxyurea and followed for one year
Drug: Hydroxyurea
Children at risk of developing stroke (TCD values>200cm/s) will be given 20mg/kg of Hydroxyurea
Other Name: Oxyurea

Primary Outcome Measures :
  1. Reach [ Time Frame: 1 year ]
    The portion of children than received TCD screening at least once in the community hospital

  2. Effectiveness [ Time Frame: 1 year ]
    The proportion of children with abnormal TCD measurement started on hydroxyurea

Secondary Outcome Measures :
  1. Stroke occurrence [ Time Frame: 1 year ]
    Proportion of children with SCA identified with stroke.

  2. Clinical events among children on Hydroxyurea [ Time Frame: 1 year ]
    Proportion of children in both teaching and community hospitals with abnormal TCD (200cm/s) measurements receiving hydroxyurea with: i) pain crises ii) fever iii) acute chest syndrome and iv)severe anemia (Hgb <6g/dL).

  3. Clinical events among children not on Hydroxyurea [ Time Frame: 1 year ]
    Proportion of children with SCA not on hydroxyurea with: i) pain crises ii) fever iii) acute chest syndrome and iv) severe anemia (Hgb <6g/dL) in both teaching and community hospitals.

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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Children with diagnosis of SCA (HbSS or HbSβthal0)
  2. 2-16 years receiving care at both YDMH (community hospital) and BDTH (teaching hospital).
  3. No previous stroke

Exclusion Criteria:

  1. Children with SCA younger than 2 years or older than 16
  2. Children with stroke

2) Children already on Hydroxyurea

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05434000

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Contact: Halima Bello-Manga, MBBS,MPH +2348033470592 mamanzara@yahoo.co.uk
Contact: Bilya M Sani +2348036005052 bilyasani@yahoo.com

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Barau Dikko Teaching Hospital/Kaduna State University Recruiting
Kaduna, Nigeria
Contact: Halima Bello-Manga, MBBS, MPH    +2348033470592    mamanzara@yahoo.co.uk   
Contact: Bilya Sani, BSc    +2348036005052    bilyasani@yahoo.com   
Principal Investigator: Halima Bello-Manga, MBBS,MPH         
Sponsors and Collaborators
Barau Dikko Teaching Hospital
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Principal Investigator: Halima Bello-Manga, MBBS,MPH Barau Dikko Teaching Hospital/Kaduna State University
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Responsible Party: Barau Dikko Teaching Hospital
ClinicalTrials.gov Identifier: NCT05434000    
Other Study ID Numbers: GRANT12968632
First Posted: June 27, 2022    Key Record Dates
Last Update Posted: June 27, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: When study is completed
Access Criteria: Access will be granted with permission

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Barau Dikko Teaching Hospital:
Sickle Cell Anaemia
Transcranial Doppler Ultrasound
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Genetic Diseases, Inborn
Antineoplastic Agents
Antisickling Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors