Breast milk provides numerous health benefits for infants including reduced illnesses such as otitis media, respiratory andgastrointestinal infections, asthma, sudden infant death syndrome, and a reduction in the likelihood of obesity and diabetes.It is the standard of care for NICU infants. The American Academy of Pediatrics (AAP), World Health Organization(WHO), and Center for Disease Control and Prevention (CDC) recommend exclusive breastfeeding the first 6 months andideally until age 2. Breastmilk alone is not adequate to meet the needs of very low birth weight (VLBW) infants due to thehigh variability amongst mothers and higher needs of VLBW preterm neonates and infants. Therefore, human milk fed topreterm infants requires fortification (supplementation) with nutrients. Standard fortification involves adding a fixed amountof fortifier per 100ml of human milk and is the most utilized fortification method in the US. The fixed amount is determinedby the manufacturer of the human milk fortifier and assumes that all human milk contains the same amount of proteinand other macronutrients. These assumptions of the macronutrient composition of human milk have been shown tounderestimate the amount of protein a neonate and infant in the NICU is receiving and can lead to poor neurocognitiveoutcomes. Therefore, a rapid point of care test for macronutrient and micronutrient concentrations in breast milk isimperative for improving infant nutrition and essential for targeted fortification.We present an easy-to-use device that includes a test strip coupled with our smartphone application to rapidly quantifymacronutrients in human milk. These results will help a health care provider determine the fortification based onactual values and decrease conjectures for macronutrient composition of a milk sample, providing optimal targetednutrition for the most vulnerable NICU patients. Further, the rapid point of care macronutrients test will change theworkflow for failure to thrive and slow growth infants. Our device will allow for rapid and accurate diagnosis in the clinicand warrant more immediate referral to pediatric specialists e.g., if the caloric value of a sample is tested then there may beimmediate confirmation of caloric intake for the work-up of failure to thrive infants.Successful completion of the proposed Phase I program will provide critical data to expand development of our one-of-a-kind technology in a Phase II program that will be geared towards validation in a large clinical study. This study will includefurther development of easy-to-use point of care tests in human milk and demonstrate the use of our test strip as an easytool to integrate into NICU workflow enabling a custom electronic health record-friendly software to allow for our test stripresults to be analyzed and facilitate targeted fortification and family integrated therapy.
Public Health Relevance Statement: PROJECT NARRATIVE
Human milk is lifesaving in the NICU, however, for very low birth weight (VLBW) infants' human milk alone does
not provide sufficient nutrition and it is standard practice to fortify human milk for VLBW infants. The standard
practice is to add a fixed amount of fortifier per 100ml of human milk. The fixed amount is determined by the
manufacturer of the human milk fortifier assuming that all human milk contains the same amount of protein.
Standard fortification does not solve the problem of protein undernutrition in VLBW infants. Targeted fortification
improves outcomes and growth but is limited by no rapid point of care test available to quickly quantify the
macronutrient composition of human milk. We present an easy-to-use test strip device coupled with our
smartphone application to rapidly quantify macronutrients. The Macronutrient Breast Milk Test Strip and
associated smartphone application (Emily smart application) is an analytical system that uses an enzyme-based
test strip, and a smartphone camera and application as a spectrometer. This Phase I SBIR proposal will
demonstrate human milk quantification that will allow for the fortification of human milk, thus ensuring that VLBW
newborns receive the nutrients they require.
Project Terms: <0-4 weeks old><4-O-beta-D-galactopyranosyl-D-glucose> | | | 