Infant Oral Feeding Device for Use in Neonatal Intensive Care Units

DESCRIPTION (provided by applicant): Preterm infants (lt 37 weeks gestation) have difficulty with oral feeding due to immature suck, swallow, respiration, and low endurance. As the ability to feed by mouth is a criterion for hospital discharge, it is oftendelayed, leading to increased medical cost, maternal stress, and delayed mother-infant reunification. No oral feeding device currently exists to assist infants in neonatal intensive care units (NICUs) who encounter oral feeding difficulties. The PI's research over the last 20 years has focused on understanding the development of preterm infants' oral feeding skills and developing evidence-based efficacious interventions/therapies to enhance their oral feeding performance. During this time, she identified that conventional bottles hamper infants' natural oral feeding skills due to 2 specific inherent physical properties. As such, she developed an infant oral feeding device (the PreemiUm) demonstrating that the elimination of both hindrances allows infants tofeed at their own pace, improves their feeding skills and enhances their performance with no adverse events. This work is published. The aims of this Phase I SBIR application are to develop safe- and simple-to-use commercial version(s) of the PreemiUm andto verify that their mechanical and clinical properties replicate those of our Lab version. The PreemiUm will be low cost, safe for infants, easy to use and clean for caregivers, practical and economical. Material used will meet the requirements recommended by the Consumer Product Safety Improvement Act (CPSIA) and the FDA (www.hhs.gov/safety/bpa/) Following confirmation of the PreemiUm mechanical properties, its clinical validation will be based on the bottle feeding performance of 2 groups of preterm infants (d 32 weeks gestation). Caregivers and parents will be blinded to the study. Experimental infants will be fed with the PreemiUm and their control counterparts with a sham bottle identical in shape, looks, and volume as the PreemiUm. The primary outcome will be days from introduction to independent oral feeding. Secondary outcomes will include hospital duration and cost, along with the following measures monitored when infants are taking 1-2, 3-5, and 6-8 oral feedings/day: overall transfer (% total volume taken/ total volume to be taken); proficiency (% volume taken the first 5 min/total volume to be taken); rate of milk transfer over the entire feeding (ml/min); feeding duration (min); milk loss (% volume lost/ volume taken); occurrence of adverseevents. Once appropriate commercial versions are available, production and commercial penetration of the PreemiUm will be launched. It will be introduced to the hospital market beginning with infants in NICUs as this is where the PI's expertise lies. It will expand to all infants demonstrating oral feeding difficulties, e.g., those with congenital anomalies, developmental/intellectual disabilities, and healthy term infants in the community with bottle feeding difficulties for unclear reasons. PUBLIC HEALTH RELEVANCE: With immature oral feeding skills, many preterm infants have difficulty transitioning from tube to independent oral feeding. This often delays their hospital discharge, increases medical cost, and prolongs mother-infant separation. Wehave developed a novel infant oral feeding device (the PreemiUm) and demonstrated that, when feeding with the PreemiUm vs. a conventional feeding bottle, infants' oral feeding performance and efficiency are significantly improved. Of importance to note, infants do so while using more mature sucking skills. The commercial availability of the PreemiUm has the potential of accelerating attainment of independent oral feeding, shortening hospitalization, decreasing medical cost, and accelerating mother-infant reunification for infants in neonatal intensive care units.