A Noninvasive Portable Device to Evaluate Feeding Problems in Infants

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 2R44HD038234-04
Agency Tracking Number: HD038234
Amount: $2,640,942.00
Phase: Phase II
Program: SBIR
Awards Year: 2010
Solicitation Year: N/A
Solicitation Topic Code: NICHD
Solicitation Number: N/A
Small Business Information
DUNS: 013185561
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (503) 705-3089
Business Contact
Phone: (503) 705-3089
Research Institution

DESCRIPTION (provided by applicant): Feeding problems are a frequent harbinger of nascent neurological damage and are a major obstacle in transitioning infants from hospital nursery to discharge. Severe problems often require repeated hospitalization and tube feeding. Refractory feeding problems contribute significantly to the high cost of health care. Dysfunctional sucking in the newborn, in the absence of any focal neurological symptoms, is known to correlate with developmental delay evident at 24 months of age. It is estimated that 57-92% of infants with brain damage have dysphagia and are at higher risk of long-term malnutrition, growth failure and higher mortality rates. Early, accurate diagnosis would be of great help to these infants, as they would receive the most appropriate treatment at an earlier age. We describe a novel device (an Orometer) and data analytical system (Suck Editor) that we have developed to quantify nutritive sucking behavior and the results when it is used to test normal full-term infants, premature infants, infants with feeding problems and serious illness. We examine an intriguing result in a small sample of infants with submucosal cleft palate and velopharyngeal insufficiency. We posited that a quantitative and permanent record of infant sucking comparable to EEG, EKG or EMG might be of value in supplementing the current scoring systems tools used to assess an infant's feeding competence prior to discharge and perhaps of value for predicting long-term outcome, and now plan to test that hypothesis. Work conducted during our Phase I and Phase II SBIR grants has established that the Orometer is portable, noninvasive, and that it produces durable and reliable records of pressure changes which occur during infant feeding. It has already been proved to be a valuable tool for documenting oral-motor behavior; the records it produces are a useful supplement to subjective feeding observations. We will endeavor to bring it to market quickly for these sound reasons alone, but we have reason to believe that when larger populations are studied, it will prove capable of far more. This proposal seeks to refine the product design of the Orometer to a market-ready modular form; test our existing prototypes in two clinical centers in targeted populations-of-interest; perform expanded clinical trials in two clinical centers; and finally obtain sufficient data to support FDA approval for the re-engineered device. We will endeavor to establish additional uses for the Orometer. Finally, we describe specialized extensions of this device which hold research potential. These designs will extend and quantify simultaneous observations of suck, swallow and breathing, and allow serious researchers to study the coordination of all three vital functions in new depth. PUBLIC HEALTH RELEVANCE: This research is important because it will produce a product to help clinicians observe infant feeding more accurately, leading to improved care for young infants with feeding difficulties. For premature infants, clinicians will use objective measurement to improve their understanding of when such infants can thrive in a home environment, leading to shorter hospital stays, lower costs, less trauma for families, and improved childhood nutrition.

* Information listed above is at the time of submission. *

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