Active Bottle for Preterm Infant Oral Feeding

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Of approximately 4 million live births in the United States in year 2000, 11.6 percent or about 471,000 infants were born less than 37 weeks gestation (Martin et al.). Preterm infants may spend days or weeks in a neonatal intensive care unit (NICU), where they are nutritionally supported by nasogastric feeding tube, until they are capable of oral feeding by means of sucking and swallowing and can digest human milk or formula (Schanler & Lau). For otherwise healthy preterm infants, oral feeding difficulty is the single most important determinant of prolonged stays in intensive care (Eichenwald et al.). A fundamental component of oral feeding difficulty is coordination of breathing with sucking and swallowing. The development and clinical evaluation of a computer-controlled active bottle milk delivery system is proposed, aimed at promoting coordination of breathing with sucking and swallowing, and reducing the number of days that preterm infants remain in intensive care. Serious health consequences can result from persistent oral feeding problems, including malnutrition and impaired intellectual growth (Jones, Morgan & Shelton). Moreover, it is estimated that in the United States, the cost of neonatal intensive care ranges between 50,000 and 100,000 dollars per patient (Zupancic et al.). A reduction in number of NICU days associated with oral feeding difficulty could substantially reduce this cost and the risk of feeding-related health problems. Phase I represents a logical first step in the development process. It consists of four steps: assembly, bench test and calibration of the active bottle; simulation of use by human infants; evaluation of human factors through contact with health professionals; and preparation for a Phase II in which the bottle would be tested with infants. First, a prototype is built and bench-tested to confirm that the sensors, flow control components and controller are working as intended. Second, previously recorded sucking and breathing waveforms from a pilot study of healthy term infants is "played back," and it is determined if the bottle controller correctly uses the recorded signals to regulate milk flow from the bottle. Third, we conduct human factors evaluation of the active bottle design by asking health professionals to hold and work with the prototype. We conclude with tasks necessary to begin testing with infants during a Phase II.