The Preemie Pacer An Innovative Bottle to Promote Safe and Efficient Oral Feeding in Preterm Infants

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43HD092210-01
Agency Tracking Number: R43HD092210
Amount: $149,917.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NICHD
Solicitation Number: PA16-302
Timeline
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-04-01
Award End Date (Contract End Date): 2017-12-31
Small Business Information
865 KINGSGATE DR, O Fallon, MO, 63368-4799
DUNS: 079784758
HUBZone Owned: N
Woman Owned: Y
Socially and Economically Disadvantaged: N
Principal Investigator
 THOMAS OLEKSY
 (314) 956-1272
 tomoleksy622@gmail.com
Business Contact
 TOM OLEKSY
Phone: (314) 956-1272
Email: preemiepacer@gmail.com
Research Institution
N/A
Abstract
PROJECT SUMMARY ABSTRACT There are infants born preterm each year in the United States alone Preterm infants often necessitate care in the neonatal intensive care unit One of the final milestones to be achieved in order to be discharged from the neonatal intensive care unit is oral feeding Oral feeding can be a challenge for infants born preterm as they do not have the maturity that allows for coordinated sucking swallowing and breathing Many infants will suck and swallow and their failure to breathe will result in dangerous physiological fluctuations To help with this pacing techniques can be used Cautious caregivers can intermittently pull the bottle nipple out of the infant s mouth to encourage breathing and recovery This can be disruptive to the feeding process can result in significant energy expenditure and can be stressful for parents To address this problem the Preemie Pacer bottle is being developed The Preemie Pacer has an internal mechanism that interrupts the flow of milk to the nipple intermittently to enable the infant to pause and breathe The long term goal of this project is to develop an innovative bottle that will address the problems that preterm infants experience during early oral feeding allowing early feeds to be done safely and efficiently The project aims are to develop prototypes of the Preemie Pacer and to assess the acceptability of the Preemie Pacer among parents of preterm infants and neonatal intensive care unit health care professionals To achieve this the concept of the Preemie Pacer will be converted to D and then D drawings Prototypes will be made and modified when they do not meet established design criteria for form and function Testing will be conducted on a breast pump and modifications of the original prototype are expected before all established design criteria are met Focus groups of neonatal intensive care unit professionals and parents will be used to assess the acceptability and to determine additional design needs and it is expected that one final modification of the prototype will be made after parent and health care professional feedback in order to optimize the design This work will set the stage for clinical trials in Phase II The Preemie Pacer can have a significant impact on the care that preterm infants receive If safe and efficient oral feeding can be achieved even a few days earlier significant health care dollars can be saved and infants can be discharged to their homes earlier In addition parents can potentially have more success and confidence in feeding their high risk preterm infants PROJECT NARRATIVE Preterm infants can have long hospitalizations and safe and efficient feeding is often the final milestone needed in order to be discharged due to the difficulty of coordinating sucking swallowing and breathing The Preemie Pacer bottle will improve early feeding by reducing and interrupting the flow of milk to enable better coordination of feeding in preterm infants The Preemie Pacer can have a significant impact on public health by reducing the length of stay in a hospital by days or possibly weeks reducing stress and dangerous physiological fluctuations and promoting increased success and confidence among parents with feeding their preterm infants

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

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