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Development and evaluation of diffuse correlation spectroscopy to monitor cerebral blood flow and detect intraventricular hemorrhage in extremely premature infants

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R42NS110337-01A1
Agency Tracking Number: R42NS110337
Amount: $149,969.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 103
Solicitation Number: PA18-574
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-09-30
Award End Date (Contract End Date): 2021-03-31
Small Business Information
1173 MAIN ST
Bolton, MA 01740-1208
United States
DUNS: 081073502
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (857) 234-9249
Business Contact
Phone: (617) 877-9734
Research Institution
BOSTON, MA 02115-6110
United States

 Domestic Nonprofit Research Organization

PROJECT SUMMARY ABSTRACT Every year in the United States aboutof theinfants born extremely prematureandltweeks gestational age and andltg birth weightELGAdevelop intraventricular hemorrhageIVHIVH is associated with high risk for cerebral palsy and significant intellectual disabilitycausing lifelong implications for affected children and their families and considerable economic burdenIVH is caused by the rupture of the fragile capillaries in the germinal matrix which cannot withstand fluctuations in cerebral blood flowCBFIn andgtof casesthese injuries occur during the first three postnatal days during a period of cardiorespiratory instability that has a direct effect on CBFwhich results in periods of cerebral hypoand hyper perfusionCurrent management strategiessuch as changes in ventilation or inotrope supportare blind to the impact on CBFImproved bedside technologies to continuously monitor CBF are urgently needed to allow the clinician to make informed decisionsto optimize current strategies and foster the development of new interventions to reduce the incidence of IVH in ELGA infants and to improve developmental outcomesBuilding onMedical founding team s ten years of success measuring infants with non invasive bedside optical methodswe propose to design and build a novel fast multi distance diffuse correlation spectroscopyDCSsystemoptimized for continuous monitoring of CBFi in ELGA infantsDCS directly quantifies an index of cerebral blood flowCBFiby measuring the temporal fluctuations of light generated by the dynamic scattering of moving red blood cellsTo be of use in the ELGA infantthis bedside monitor needs to be safecontinuousprecisereliablequantitative and gently wearableThese pre requisites will be met by designing an optical sensor which can be gently applied to the ELGA infantThe novel DCS system will be initially tested by theMedical s team in phantoms to verify performance and demonstrate precision and accuracy of flow estimatesThe system will then be tested in more maturestable premature infants at the Brigham and Womenandapos s HospitalBWHNICU to evaluate feasibility of long measurementscompatibility with the NICU environmentskin integrity after long monitoring periodsand in vivo algorithm validationFinallythe device will be used inELGA infants during the firsthours of life to test our hypothesis that DCS measured CBFi fluctuations and pressure passive events correlate with incidence and severity of IVHOur goal is to provide a much needed cerebral blood flow monitor to guide individualized treatment with the goal of reducing the risk of IVH and improving long term neurodevelopmental outcomes among ELGA infantsThis study inELGA infants will set the stage for a larger trial alongside commercialization PROJECT NARRATIVE There is a great need for a bedsidenon invasive and continuous neuromonitoring tool to provide a robust measure of cerebral blood flow in premature infantsWe propose to develop a novel near infrared diffuse correlation spectroscopyDCSsystem optimized for monitoring of the cerebral blood flow index in extremely premature infantsThe successful developmentvalidation and demonstration of clinical feasibility and effectiveness of our proposed technology will lead to new patient management approaches for reducing neurological injuryprotecting neurocognitive functionand reducing the overall morbidity and mortality associated with prematurity

* Information listed above is at the time of submission. *

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