Rapid Nutritional Analysis of Breast Milk for Neonatal Intensive Care Units For preterm infants, growth in the first weeks of life is critical to optimal lifelong growth and development. The American Academy of Pediatrics (AAP) has recommended that all preterm infants receive mother?s milk or banked human donor milk if mother?s milk is unavailable or in low supply. Although breastmilk (BM) is considered the optimal nutrition for all infants, it has tremendous variation in protein composition. Despite this, the current standard-of-care is the fortification of BM based on the assumption that all BM has the same base protein content. Protein supplementation beyond this standard amount is initiated once an infant?s growth falters, at which point both somatic and brain growth may have already been compromised. Neonatal intensive care units (NICUs) are limited in their ability to individually, custom fortify BM, as there is no point-of-care (POC) tool available in the US to measure BM protein, limiting the clinician?s ability to provide optimal nutrition to the vulnerable preterm infant. Current analytic lab methods to analyze BM such as the gold standard Kjehldahl method are lengthy and cumbersome, requiring trained personnel to conduct chemical digestion and complicated BM processing steps. Commercial milk analyzers based on infrared measurement are available, but they are expensive and bulky (not amenable to POC use). New technologies to provide bedside measurement of BM protein are urgently needed, given the long-term impact of optimal protein intake. The overall goal of this program is to develop a rapid, accurate, and cost-effective electrochemical POC quantitative BM protein assay. We have chosen to focus on measurement of BM protein because: 1) early protein intake has been clearly linked to long-term growth and developmental outcome; and 2) feasible and low-risk supplementation strategies to respond to low BM protein are readily available. In close collaboration with Brigham and Women?s Hospital, Giner, Inc. (Giner) will 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 detection (LOD) goal of 0.1 g/dL and a milk protein range of 0.1 ? 5 g/dL. Fully developed, Giner?s test will be conducted similar to a bedside blood sugar check, where a nurse can fortify the BM based on immediately available results. This will allow for longitudinal measurements of BM protein and timely, personalized 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 rapid, accurate, and cost-effective total breastmilk (BM) protein assay for use at point-of-care (POC). Giner, Inc., in close collaboration with the Department of Pediatric Newborn Medicine at Brigham and Women?s Hospital, will develop an electrochemical total protein assay and demonstrate a prototype for quantitative detection of BM protein with an initial lower limit of detection (LOD) goal of 0.1 g/dL and a detection range of 0.1 ? 5 g/dL.
