Status:
COMPLETED
Hydroxyurea Therapy for Neurological and Cognitive Protection in Pediatric Sickle Cell Anemia in Uganda ( BRAINSAFE-II )
Lead Sponsor:
Global Health Uganda LTD
Collaborating Sponsors:
Columbia University
University of Pittsburgh
Conditions:
Sickle Cell Anemia in Children
Eligibility:
All Genders
3-9 years
Phase:
PHASE3
Brief Summary
Worldwide, an estimated 200,000 babies are born with Sickle Cell Anemia (SCA) annually. Affected children suffer chronic ill health with some having frequent hospitalization. The patients are also at ...
Detailed Description
Annually, an estimated 200,000 babies are born with Sickle Cell Anemia (SCA) worldwide. Affected children often suffer repeated acute illnesses and chronic ill health from vascular occlusive phenomeno...
Eligibility Criteria
Inclusion
- Documented laboratory diagnosis of HbSS or HbS-B 0 thalassemia (both types are treated equally in SCA studies)
- Ages 3 through 9 years (inclusive) at enrolment
- To ensure clinic follow-up, child has attended Mulago Hospital Sickle Cell Anaemia (SCA)clinic 2 times in the prior 4 years, or at least once in the past 2 years if younger than \< 4 years
- No history of hydroxyurea use for longer than 6 months
- Parent/legal guardian has provided a written consent (and if child is ≥8 years of age, has provided assent)
Exclusion
- History of neurological abnormality known before age 4 months (to avoid those with non SCA brain injury)
- Child is currently enrolled in another clinical intervention trial
- Prior stroke as detected by standard Pediatric NIH Stroke Scale (PedNIHSS) examination
- Temporary exclusion criteria
- Pre-existing hematological toxicity
- Hemoglobin \<4.0 gm/dL
- Hemoglobin \<6.0 gm/dL with Absolute Reticulocyte Count \<100 x 10 9/L
- Absolute Reticulocyte Count \<80 x 109/L with Hemoglobin \<7.0 gm/dL
- Platelets \<80 x 109/L
- Absolute Neutrophil Count \<1.0 x 109/L
- Found to be with acute illness at enrolment with fever in last 1 week, respiratory infection, etc.
- History of a sickle crisis within the prior 2 weeks, or blood transfusion within the past 90 days Participants with temporary exclusion can be enrolled later when stable or the excluding criteria has resolved
Key Trial Info
Start Date :
March 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2025
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT04750707
Start Date
March 9 2021
End Date
March 10 2025
Last Update
April 17 2025
Active Locations (1)
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1
Global Health Uganda
Kampala, Uganda, +256