Active Bottle for Home Care of Dysphagic Infants - Phase II

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 2R44HD049954-02
Agency Tracking Number: HD049954
Amount: $1,495,930.00
Phase: Phase II
Program: SBIR
Awards Year: 2008
Solicitation Year: 2008
Solicitation Topic Code: N/A
Solicitation Number: PHS2007-2
Small Business Information
DUNS: 004627316
HUBZone Owned: Y
Woman Owned: Y
Socially and Economically Disadvantaged: Y
Principal Investigator
 () -
Business Contact
Phone: (781) 890-1338
Research Institution
DESCRIPTION (provided by applicant): Prematurely born infants and term infants with congenital heart disease often develop neurogenic dysphagia, a life-threatening condition characterized by difficulty in coordinating swallowing and breathing during breast and bottle feeding, resulting in a failure to gain weight and increased risk of pneumonia or death, due to taking fluid into the lungs. During Phase I, Infoscitex successfully designed and built a prototype of a computer-controlled bottle feeding system for dispensing either thin-consistency or nectar-thick fluids to dysphagic infants on the basis of sucking and respiration sensor signals. Phase II makes several major advances in the design and capabilities of the active bottle that have re sulted from the Phase I bench tests and Dr. Goldfield's ongoing research into swallowing by premature infants. The Active Bottle for infants with neurogenic dysphagia is evaluated during Phase II by means of a clinical trial consisting of tests involving d ispensing of thin or thick fluids. At the same time, the Active Bottle is advanced towards a commercial home-care product. Close collaboration between the engineering team at Infoscitex and the clinical teams at both Children's Hospital Boston and Beth Israel Deaconess Medical Center throughout the project, will ensure that clinical trials with the Active Bottle are successful. Positive clinical results, along with the evolution of the Active Bottle towards a more ergonomic, less expensive, home car e system will allow infants with feeding problems caused by neurogenic dysphasia a safer and more effective means for feeding, while reducing development of aspiration-induced pneumonia, and hastening NICU discharge of infants with neurogenic dysphagia, re ducing NICU cost and allowing infants to come home to their families sooner. PUBLIC HEALTH RELEVANCE Premature infants born less than 33 weeks gestational age, or born at term with congenital heart disease, have a higher risk of brain injury than h ealthy term infants. These two groups of infants are also more likely to experience swallowing and other coordination problems during bottle feedings. Swallowing disorder due to neurological abnormality is called neurogenic dysphagia. During care in the NI CU, and eventually during the long term home care after hospital discharge, infants with neurogenic dysphagia may require a feeding protocol that manipulates the properties of the fluids being fed to them. This research is aimed at the development of a com puter-controlled milk delivery system that would 1) encourage and maintain proper oral feeding behavior in infants with neurogenic dysphagia, 2) reduce development of aspiration-induced pneumonia, 3) hasten NICU discharge of infants with neurogenic dysphag ia, reducing NICU cost, and allowing infants to come home to their families sooner.

* information listed above is at the time of submission.

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