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Noninvasive Monitoring of Total Hemoglobin Concentration in Neonates

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41HD094542-01A1
Agency Tracking Number: R41HD094542
Amount: $179,722.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NICHD
Solicitation Number: PA17-303
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-08-05
Award End Date (Contract End Date): 2019-07-31
Small Business Information
1700 THE STRAND, STE 1.200
Galveston, TX 77555-0001
United States
DUNS: 801196960
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (832) 899-4675
Business Contact
Phone: (409) 772-8144
Research Institution
GALVESTON, TX 77555-5302
United States

 Nonprofit College or University

AbstractIn newborn infants intermittent total hemoglobin concentrationTHbmeasurement represents an
essential diagnostic testHoweverblood sampling in neonates results in iatrogenic anemiais a painful
experience for infantsand is a tedious procedure for health care personnelBlood sampling forTHbmeasurements represents a high proportion of painful procedures required in infantsyet heel sticksthe most
common type of blood sampling in infantsproduce blood samples that poorly correlate with blood drawn by
venipunctureAt presentthere is no noninvasive technology for accurateTHbmeasurementsThe only
commercially available noninvasive device forTHbmeasurementMasimo s Rainbow Pulse CO Oximetercorrelates poorlyRwith invasive measurements and is inaccurateNoninvasix recently demonstrated in neonates that optoacoustic technology permits easyaccuratedirectand noninvasiveTHbmeasurement by detecting and analyzing signals from the superior sagittal sinusa large central cerebral vein located immediately beneath the skullHaving established the proof of concept for
optoacousticTHbmonitoring in neonatesthis Phase I application proposes to refine that technique as a major
step toward commercialization of a device for intermittent measurementsIn this Phase I projectwhich is based
on a laboratory laser diode optoacoustic prototypeNoninvasix will collaborate with the University of Texas
Medical Branchwhich co owns NoninvasixThe research team will iteratively design and build a clinical
prototype neonatal interface and a user interface and test them in post delivery neonates by progressing through
the following specific aimsThe goal of Specific Aimis to develop a clinical prototype probeincluding headgearand a graphical
user interfaceGUIfor the noninvasive optoacoustic measurement device that will accurately measureTHbin
neonates when used by one unassisted caregiverThis Aim will consist of a three to four cycle iterative processin which a team of bioengineersnursesand clinicians will iteratively design and test the probe design in
neonatesthen revise and retest the design based on that experienceThe goal of Specific Aimis to evaluate the accuracy of noninvasiveTHbmeasurements inneonatesThe research team will noninvasively measureTHbwith the optoacoustic system and evaluate
agreement of the measurements with venipuncture samples measured using a clinical hemoximetergold
In newborns hemoglobin concentrationTHbmeasurement is an essential diagnostic
testbut it requires blood sampling that results in iatrogenic anemiais a painful
experience for infantsand is a tedious procedure for health care personnelAt presentthere is no noninvasive technology for accurateTHbmeasurementsIn this project we
will develop a probe that permits that measurement and will test it in neonates

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

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