SBIR/STTR Award attributes
Rapid Nutritional Analysis of Breast Milk for Neonatal Intensive Care Units For preterm infantsgrowth in the first weeks of life is critical to optimal lifelong growth and developmentThe American Academy of PediatricsAAPhas recommended that all preterm infants receive mother s milk or banked human donor milk if mother s milk is unavailable or in low supplyAlthough breastmilkBMis considered the optimal nutrition for all infantsit has tremendous variation in protein compositionDespite thisthe current standard of care is the fortification of BM based on the assumption that all BM has the same base protein contentProtein supplementation beyond this standard amount is initiated once an infant s growth faltersat which point both somatic and brain growth may have already been compromisedNeonatal intensive care unitsNICUsare limited in their ability to individuallycustom fortify BMas there is no point of carePOCtool available in the US to measure BM proteinlimiting the clinician s ability to provide optimal nutrition to the vulnerable preterm infantCurrent analytic lab methods to analyze BM such as the gold standard Kjehldahl method are lengthy and cumbersomerequiring trained personnel to conduct chemical digestion and complicated BM processing stepsCommercial milk analyzers based on infrared measurement are availablebut they are expensive and bulkynot amenable to POC useNew technologies to provide bedside measurement of BM protein are urgently neededgiven the long term impact of optimal protein intakeThe overall goal of this program is to develop a rapidaccurateand cost effective electrochemical POC quantitative BM protein assayWe have chosen to focus on measurement of BM protein becauseearly protein intake has been clearly linked to long term growth and developmental outcomeandfeasible and low risk supplementation strategies to respond to low BM protein are readily availableIn close collaboration with Brigham and Women s HospitalGinerIncGinerwill develop a POC BM protein measurement technology and demonstrate a Phase I prototype for quantitative detection of BM protein with an initial lower limit of detectionLODgoal ofg dL and a milk protein range ofg dLFully developedGiner s test will be conducted similar to a bedside blood sugar checkwhere a nurse can fortify the BM based on immediately available resultsThis will allow for longitudinal measurements of BM protein and timelypersonalized and optimized custom BM fortification to optimally support growth and development for every preterm infant The overall goal of this program is to develop a rapidaccurateand cost effective total breastmilkBMprotein assay for use at point of carePOCGinerIncin close collaboration with the Department of Pediatric Newborn Medicine at Brigham and Women s Hospitalwill develop an electrochemical total protein assay and demonstrate a prototype for quantitative detection of BM protein with an initial lower limit of detectionLODgoal ofg dL and a detection range ofg dL
