There are 450,000 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 2D and then 3D 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 4 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.

Public Health Relevance

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.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43HD092210-01
Application #
9347983
Study Section
Special Emphasis Panel (ZRG1-RPHB-R (12)B)
Program Officer
Koso-Thomas, Marion
Project Start
2017-04-01
Project End
2017-09-30
Budget Start
2017-04-01
Budget End
2017-09-30
Support Year
1
Fiscal Year
2017
Total Cost
$149,917
Indirect Cost
Name
Preemie-Pacer, LLC
Department
Type
Domestic for-Profits
DUNS #
079784758
City
O'Fallon
State
MO
Country
United States
Zip Code
63368