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Comprehensive, Near Patient Assessment of Severe Hypoglycemia in Newborns Using Low Blood Volume

Award Number: R44HD092154
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/01/2018
PERIOD OF PERFORMANCE END DATE: 04/30/2021

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Comprehensive, Near Patient Assessment of Severe Hypoglycemia in Newborns Using Low Blood Volume - Hypoglycemia is the most common metabolic disorder in newborns and places the neonate at increased risk of seizures and permanent brain injury. The etiology of severe neonatal hypoglycemia -- which affects around 25,000 newborns each year in the U.S. -- is complex, with underlying causes including hyperinsulinism, cortisol and/or growth hormone (GH) deficiencies, and defects in glycogen metabolism. Comprehensive evaluation of these physiological pathways is essential to guide appropriate, effective medical interventions. However, the current panel of laboratory assays requires relatively large volumes (3 mL or more) of whole blood, making newborn assessment challenging, particularly in preterm newborns. More importantly, routine turnaround times for these assays may be 48 hours or more, leading to critical delays in life-saving treatment. The overall goal of this Fast Track SBIR project is to develop a comprehensive near patient digital microfluidic system, FINDER, for the rapid assessment of severe, persistent hypoglycemia disorders in newborns using microliter volumes of whole blood. FINDER will accept single use cartridges and will multiplex 6 assays for the detection of insulin, cortisol, growth hormone, glucose, β-hydroxybutyrate and free fatty acids using < 50 µL of whole blood for all assays. Run time will be approximately 45 minutes. The team at Baebies will collaborate with leading clinical investigators in Neonatology (Dr. Michael Cotten) and Pediatric Endocrinology (Dr. Michael Freemark) at Duke University on this project. The system proposed herein addresses a critical unmet clinical need for rapid testing at the time of hypoglycemia; the final product will be substantially differentiated from current laboratory based assays in terms of lower blood volume, lower cost and faster time-to-result. The Phase I Specific Aims include: 1) optimize assay-ready reagents for on-cartridge drying and storage; 2) translate six laboratory based assays to the digital microfluidic cartridge and establish preliminary analytical performance; and 3) demonstrate preliminary feasibility of the assay panel on whole blood. The key milestone for progression to Phase II will be the successful demonstration of all individual assays on-cartridge using dry reagents and with high reliability and precision. A small feasibility study in Aim 3 will test our assay performance against clinical standard laboratory assays. The Specific Aims for Phase II are: 1) multiplex all assays to perform simultaneously on the same cartridge; 2) perform analytical validations to determine device performance; and 3) preliminary clinical validation of the hypoglycemia panel: results obtained with FINDER will be compared to standard values obtained in the Duke Clinical Laboratory. At the conclusion of Phase II, we will have a commercializable product for rapid, efficient and accurate assessment of severe hypoglycemia in newborns using microliter volumes of whole blood. We will seek FDA approval of the final product, which will initially be marketed for use in pediatric patients in U.S. hospitals, with a future market towards other patients who may benefit from the innovative features of the platform.


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: 2023 ( Subtotal = -$52,404 )
2023	2019	BAEBIES, INC.	25 ALEXANDRIA WAY	DURHAM	NC	27703	DURHAM	USA	Child Health and Human Development Extramural Research	000	3	3/14/2023	NON-COMPETING CONTINUATION	-$52,404
														Subtotal = -$52,404

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2019	BAEBIES, INC.	615 DAVIS DR STE 800	MORRISVILLE	NC	27560	WAKE	USA	Child Health and Human Development Extramural Research	000	3	11/8/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $792,119 )
2019	2019	BAEBIES, INC.	615 DAVIS DR STE 800	DURHAM	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	001	3	8/6/2019	NON-COMPETING CONTINUATION	$792,119
2019	2017	BAEBIES, INC.	615 DAVIS DR STE 800	DURHAM	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	000	1	5/21/2019	NEW	$0
														Subtotal = $792,119

Issue Date FY: 2018 ( Subtotal = $767,573 )
2018	2018	BAEBIES, INC.	615 DAVIS DR STE 800	DURHAM	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	000	2	4/23/2018	EXTENSION WITH OR WITHOUT FUNDS	$767,573
														Subtotal = $767,573

Issue Date FY: 2017 ( Subtotal = $272,066 )
2017	2017	BAEBIES, INC.	615 DAVIS DR STE 800	DURHAM	NC	27709	DURHAM	USA	Child Health and Human Development Extramural Research	000	1	4/10/2017	NEW	$272,066
														Subtotal = $272,066

Grand Total All Awards = $1,779,354

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Comprehensive, Near Patient Assessment of Severe Hypoglycemia in Newborns Using Low Blood Volume

Award Number: R44HD092154

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 05/01/2018

PERIOD OF PERFORMANCE END DATE: 04/30/2021

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