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Endoscopic versus Shunt Treatment of Hydrocephalus in Infants

Award Number: U01NS107486
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2019
PERIOD OF PERFORMANCE END DATE: 08/31/2027

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Endoscopic versus Shunt Treatment of Hydrocephalus in Infants - Hydrocephalus primarily affects infants under one year of age. The traditional treatment for hydrocephalus is cerebrospinal fluid (CSF) shunt. Life-time complications of CSF shunts are high and expensive, with annual hospital charges of nearly $2.0 billion, accounting for 3.1% of all pediatric hospital charges. As shunt complications also adversely impact quality of life, it is not surprising that surveys of families affected by hydrocephalus show that they desperately desire shunt-free treatment options. The most promising shunt-free treatment for infant hydrocephalus is endoscopic third ventriculostomy with choroid plexus cauterization (ETV+CPC), which our Hydrocephalus Clinical Research Network (HCRN) and others have shown to be safe and viable. However, the cognitive outcome of ETV+CPC compared to shunt is not known. Our data suggest that most families would accept the risks of ETV+CPC for the chance to be free of shunt, but only if initial treatment with ETV+CPC will not lead to noticeable sacrifice in cognitive outcome compared to shunting. With this U01 proposal, we aim: 1. To determine, in infants ≤12 months corrected age, with hydrocephalus requiring treatment at tertiary care pediatric neurosurgery centers in North America, does ETV+CPC compared to shunt result in non-inferior cognitive outcome at 12 months from surgery, as measured by Bayley Scales of Infant and Toddler Development (Bayley-III) Cognitive Scale with a non-inferiority margin of 1.5. 2a. To determine, in the same cohort, if ETV+CPC compared to shunt results in non-inferior Bayley-III Motor/Language Scales or Vineland-3 Scales. 2b. To compare other measures of treatment performance (brain/ventricle volume, treatment failure, hospital days, repeat surgery, use of imaging) and complications between treatment arms. 3a. To determine the effect of ETV+CPC and shunt on cerebral structural connectivity, with diffusion MR fractional anisotropy (FA) in the corpus callosum 12 months after surgery. 3b. To define the relationships between pre-operative brain/ventricular volume and cerebrospinal fluid (CSF) NCAM-1 level to post-operative corpus callosum FA and Bayley-III Cognitive Scale 12 months after surgery. 3c. To define the relationships between change in brain/ventricular volume (pre-operatively to 12 months post-operatively) to FA in the corpus callosum and corticospinal tract and Bayley-III Cognitive and Motor Scales 12 months post-operatively. To do this, we plan an RCT comparing ETV+CPC and shunt in infants with hydrocephalus, within the HCRN, a committed group of 14 leading North American pediatric neurosurgical centers with a long track-record of successful collaborative clinical research and RCTs in hydrocephalus. Optimal cognitive outcome, the primary concern of families, will therefore, be our primary outcome. Assessment of dMRI, a validated, non-invasive method of measuring white matter microstructural integrity and structural connectivity in the developing brain, will provide further insight into the developmental consequences of these 2 treatments. This RCT will help families determine the optimal treatment of hydrocephalus for their child.


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: 2026 ( Subtotal = $1,079,283 )
2026	2026	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	7	9/3/2026	SUPPLEMENT FOR EXPANSION	$25,170
2026	2026	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	7	8/24/2026	NON-COMPETING CONTINUATION	$985,459
2026	2026	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	003	7	9/4/2026	SUPPLEMENT FOR EXPANSION	$47,915
2026	2026	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	004	7	9/5/2026	SUPPLEMENT FOR EXPANSION	$20,739
2026	2025	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	6	2/25/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,079,283

Issue Date FY: 2025 ( Subtotal = $1,052,581 )
2025	2025	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	6	9/8/2025	NON-COMPETING CONTINUATION	$955,706
2025	2025	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	003	6	9/9/2025	SUPPLEMENT FOR EXPANSION	$22,440
2025	2025	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	6	9/9/2025	SUPPLEMENT FOR EXPANSION	$52,775
2025	2025	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	6	9/8/2025	SUPPLEMENT FOR EXPANSION	$21,660
														Subtotal = $1,052,581

Issue Date FY: 2024 ( Subtotal = $1,179,880 )
2024	2024	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	5	8/28/2024	NON-COMPETING CONTINUATION	$1,179,880
2024	2024	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	5	9/17/2024	NON-COMPETING CONTINUATION	$0
2024	2023	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	4	8/28/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,179,880

Issue Date FY: 2023 ( Subtotal = $1,544,375 )
2023	2023	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	4	9/14/2023	NON-COMPETING CONTINUATION	$1,544,375
														Subtotal = $1,544,375

Issue Date FY: 2022 ( Subtotal = $1,492,187 )
2022	2022	UNIVERSITY OF UTAH, THE	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	9/19/2022	NON-COMPETING CONTINUATION	$1,492,187
														Subtotal = $1,492,187

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	UNIVERSITY OF UTAH, THE	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	2	8/25/2021	NON-COMPETING CONTINUATION	$0
2021	2020	UNIVERSITY OF UTAH, THE	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	2	4/15/2021	NON-COMPETING CONTINUATION	$0
2021	2019	UNIVERSITY OF UTAH, THE	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	1/29/2021	NEW	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $1,497,695 )
2020	2020	UNIVERSITY OF UTAH, THE	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	8/19/2020	NON-COMPETING CONTINUATION	$1,497,695
														Subtotal = $1,497,695

Issue Date FY: 2019 ( Subtotal = $1,746,515 )
2019	2019	UNIVERSITY OF UTAH, THE	201 S PRESIDENT CIRCLE RM 408	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	1	9/19/2019	NEW	$0
2019	2019	UNIVERSITY OF UTAH, THE	201 S PRESIDENT CIRCLE RM 408	SALT LAKE CITY	UT	84112	SALT LAKE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	9/11/2019	NEW	$1,746,515
														Subtotal = $1,746,515

Grand Total All Awards = $9,592,516

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Endoscopic versus Shunt Treatment of Hydrocephalus in Infants

Award Number: U01NS107486

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/15/2019

PERIOD OF PERFORMANCE END DATE: 08/31/2027

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