In newborn infants intermittent total hemoglobin concentration [THb] measurement represents an essential diagnostic test. However, blood sampling in neonates results in iatrogenic anemia, is a painful experience for infants, and is a tedious procedure for health care personnel. Blood sampling for [THb] measurements represents a high proportion of painful procedures required in infants, yet heel sticks, the most common type of blood sampling in infants, produce blood samples that poorly correlate with blood drawn by venipuncture. At present, there is no noninvasive technology for accurate [THb] measurements. The only commercially available noninvasive device for [THb] measurement, Masimoâs Rainbow Pulse CO-Oximeter, correlates poorly (R2 = 0.44) with invasive measurements and is inaccurate. Noninvasix recently demonstrated in neonates that optoacoustic technology permits easy, accurate, direct, and noninvasive [THb] measurement by detecting and analyzing signals from the superior sagittal sinus, a large central cerebral vein located immediately beneath the skull. Having established the proof-of-concept for optoacoustic [THb] monitoring in neonates, this Phase I application proposes to refine that technique as a major step toward commercialization of a device for intermittent measurements. In this Phase I project, which is based on a laboratory laser diode optoacoustic prototype, Noninvasix will collaborate with the University of Texas Medical Branch, which co-owns Noninvasix. The 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 aims: The goal of Specific Aim 1 is to develop a clinical prototype probe, including headgear, and a graphical user interface (GUI) for the noninvasive optoacoustic measurement device that will accurately measure [THb] in neonates when used by one unassisted caregiver. This Aim will consist of a three-to-four-cycle iterative process, in which a team of bioengineers, nurses, and clinicians will iteratively design and test the probe design in neonates, then revise and retest the design based on that experience. The goal of Specific Aim 2 is to evaluate the accuracy of noninvasive [THb] measurements in 30 neonates. The research team will noninvasively measure [THb] with the optoacoustic system and evaluate agreement of the measurements with venipuncture samples measured using a clinical hemoximeter (gold standard).
Public Health Relevance Statement: Narrative In newborns hemoglobin concentration [THb] measurement is an essential diagnostic test, but it requires blood sampling that results in iatrogenic anemia, is a painful experience for infants, and is a tedious procedure for health care personnel. At present, there is no noninvasive technology for accurate [THb] measurements. In this project we will develop a probe that permits that measurement and will test it in neonates.
Project Terms: Acceleration; Agreement; Anemia; base; Biomedical Engineering; Birth Weight; Blood; Blood specimen; Blood Tests; Blood Vessels; Businesses; Caregivers; cerebral vein; Cerebrum; Clinical; Clinical Nurse Specialists; commercialization; Concentration measurement; Coupled; cranium; Department of Defense; design; Devices; Diagnosis; Diagnostic; Diagnostic tests; Emerging Technologies; experience; Fiber; Frequencies; Funding; Goals; Gold; graphical user interface; Health Personnel; Heel; Hemoglobin; Iatrogenesis; Image; Individual; Infant; infant monitoring; iterative design; Laboratories; Lasers; Legal patent; Low Birth Weight Infant; Measurement; Measures; Medical; Methods; Monitor; Near-Infrared Spectroscopy; Neonatal; Neonatal Intensive Care Units; neonate; Newborn Infant; Nurses; Optics; Oxygen; Pain; Patients; Phase; Physiologic pulse; Procedures; Process; programs; prototype; Research; Sampling; Scalp structure; Signal Transduction; Small Business Technology Transfer Research; soft tissue; Superior sagittal sinus; System; Techniques; Technology; Testing; Texas; Time; Transfusion; transmission process; United States National Institutes of Health; Universities; Venipunctures; Venous; Very Low Birth Weight Infant; Wor
