SBIR Phase I: Development and Testing of a Mini Wearable Device that Doctors Can use to Know if it is too Soon or Not to Send A premature Baby Home

Period of Performance: 12/15/2016 - 09/30/2017

$225K

Phase 1 SBIR

Recipient Firm

BrainStem Biometrics
2352 Main St Ste 201
Concord, MA 01742
Firm POC, Principal Investigator

Abstract

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project would be to make it safer to send premature babies home after their stay in the NICU. They will be more likely to grow and thrive while they regain valuable bonding time with their parents. The risk of having to readmit babies would go down. Complications and maybe even SIDS could be reduced, because we would have a better way to measure and understand the development of these babies after they leave the hospital but continue to mature for the first year. Our physicians are excellent, but their decisions can only be as reliable as the information they are provided. Many cases doctors are forced to make difficult decisions between keeping a baby longer at greater cost and further separation or sending the baby home to begin a new life, but at the risk that the baby's central nervous system may not be quite up to the job of keeping the basic heart, lung and temperature at the right levels. This project will give physicians better more accurate information to reduce the guesswork and keep the babies safe. The proposed project will result in a miniature throw away sensor strip that nurses stick on the outer eyelid of a premature baby. The technology, called OMT allows us to read the innermost control signals of the deepest and most important part of the brain called the brainstem. Neuroscientists now know that one of the most important jobs that the brainstem does is to help control the most basic primitive life functions such as changing the rate of breathing, body temperature, blood pressure and heart rate. Develop a thin film sensor and instrument that is capable of successfully recording brainstem biosignals in premature babies, both technically and physiologically, and; demonstrate that it is possible to distinguish between pre-terms with and without discharge problems The project plan is to complete the design and assembly of the instrument and to sample the data from a late pre-term infant to determine basic viability of signal and satisfactory detection. Following that the team will produce a small lot of sensors and several test units to measure 9-18 young patients in three cohorts. This basic validation of the instrument and clinical value is the key next step to successful commercialization of the product.