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Burden and Risk of Neurological and Cognitive Impairment in Pediatric Sickle Cell Anemia in Uganda (BRAIN SAFE II)

Award Number: R01HD096559
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Abstract Stroke commonly occurs in children with sickle cell anemia (SCA) due to development of sickle cerebral vasculopathy (SCV) injury. SCV also can cause neurocognitive impairment. Identifiable stroke risk is associated with abnormal cerebral abnormal arterial blood flow detected by transcranial Doppler ultrasound (TCD). Most children with SCA live in Africa. Our hypotheses are that: 1) Higher burden of anemia, inflammation and malnutrition predispose African children with SCA to greater burden of SCV than in the West; 2) in Uganda, HU therapy will prevent, stabilize or improve SCV and its effects. We propose to: in Aim 1 to perform an open label, single arm clinical trial to test the three-year impact of hydroxyurea treatment for a cohort of children with SCA ages 2-9 years in Uganda on each of three clinically important outcomes: abnormal TCD, neurocognitive impairment, and first stroke. Following baseline assessments, all subjects will begin hydroxyurea therapy at about 20mg/kg daily. Changes in the frequency and severity of each outcome will be compared with age-adjusted baseline test results by repeating these three tests at 18 and 36 months; in Aim 2 to evaluate the impact of HU on structural vascular injury using MRI and MRA in a randomly selected 33% subset of this cohort at baseline and at 36 months; in Aim 3 we will assess changes to biomarkers of anemia, C-reactive protein and malnutrition status during hydroxyurea therapy, over time, compared with baseline levels, and determine their relationship to the development of brain injury and the other findings. Our proposed intervention with hydroxyurea is the only Africa-based trial to broadly prevent or ameliorate manifestations of SCV.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	GLOBAL HEALTH UGANDA LIMITED	PLOT 667 MAWANDA ROAD	KAMPALA				UGA	Child Health and Human Development Extramural Research	001	5	2/16/2024	NON-COMPETING CONTINUATION	$0
2024	2022	GLOBAL HEALTH UGANDA LIMITED	PLOT 667 MAWANDA ROAD	KAMPALA				UGA	Child Health and Human Development Extramural Research	000	4	2/15/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $521,965 )
2023	2023	GLOBAL HEALTH UGANDA LIMITED	PLOT 667, MAWANDA ROAD	KAMPALA				UGA	Child Health and Human Development Extramural Research	001	5	8/31/2023	NON-COMPETING CONTINUATION	$389,531
2023	2023	GLOBAL HEALTH UGANDA LIMITED	PLOT 667, MAWANDA ROAD	KAMPALA				UGA	Child Health and Human Development Extramural Research	002	5	9/7/2023	SUPPLEMENT FOR EXPANSION	$132,434
2023	2022	GLOBAL HEALTH UGANDA LIMITED	PLOT 667, MAWANDA ROAD	KAMPALA				UGA	Child Health and Human Development Extramural Research	000	4	12/7/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $521,965

Issue Date FY: 2022 ( Subtotal = $390,950 )
2022	2022	GLOBAL HEALTH UGANDA LIMITED	PLOT 667, MAWANDA ROAD	KAMPALA				UGA	Child Health and Human Development Extramural Research	001	4	9/2/2022	NON-COMPETING CONTINUATION	$390,950
2022	2021	GLOBAL HEALTH UGANDA LIMITED	PLOT 667, MAWANDA ROAD	KAMPALA				UGA	Child Health and Human Development Extramural Research	000	3	5/13/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $390,950

Issue Date FY: 2021 ( Subtotal = $386,000 )
2021	2021	GLOBAL HEALTH UGANDA LIMITED	PLOT 667, MAWANDA ROAD	KAMPALA				UGA	Child Health and Human Development Extramural Research	002	3	9/3/2021	NON-COMPETING CONTINUATION	$386,000
2021	2020	GLOBAL HEALTH UGANDA LIMITED	PLOT 667, MAWANDA ROAD	KAMPALA				UGA	Child Health and Human Development Extramural Research	001	2	8/16/2021	NON-COMPETING CONTINUATION	$0
2021	2019	GLOBAL HEALTH UGANDA LIMITED	PLOT 667, MAWANDA ROAD	KAMPALA				UGA	Child Health and Human Development Extramural Research	000	1	8/12/2021	NEW	$0
														Subtotal = $386,000

Issue Date FY: 2020 ( Subtotal = $401,623 )
2020	2020	GLOBAL HEALTH UGANDA LIMITED	PLOT 667, MAWANDA ROAD	KAMPALA				UGA	Child Health and Human Development Extramural Research	001	2	9/4/2020	NON-COMPETING CONTINUATION	$401,623
2020	2019	GLOBAL HEALTH UGANDA LIMITED	PLOT 667, MAWANDA ROAD	KAMPALA				UGA	Child Health and Human Development Extramural Research	000	1	10/31/2019	NEW	$0
														Subtotal = $401,623

Issue Date FY: 2019 ( Subtotal = $464,236 )
2019	2019	GLOBAL HEALTH UGANDA LIMITED	PLOT 667, MAWANDA ROAD	KAMPALA				UGA	Child Health and Human Development Extramural Research	000	1	9/11/2019	NEW	$464,236
														Subtotal = $464,236

Grand Total All Awards = $2,164,774

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Burden and Risk of Neurological and Cognitive Impairment in Pediatric Sickle Cell Anemia in Uganda (BRAIN SAFE II)

Award Number: R01HD096559

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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