R44HD097017

Development of the Couplet Care Bassinet to Support Safe Implementation of Skin-to-Skin Contact and Rooming-In on Postnatal Units - Abstract

Couplet Care, LLC is developing the Couplet Care BassinetTM, a novel infant clinical bassinet designed to support safe implementation of skin-to-skin contact and rooming-in on postnatal units.

Until recently, the standard of hospital care for healthy term newborns was to be observed and cared for by maternity staff in a nursery with other infants. However, as detailed in the World Health Organization/UNICEF report Ten Steps for Successful Breastfeeding, it is now recommended that mothers and infants "room-in" together 24 hours per day, with one hour of separation allowable for procedures outside of the postnatal unit room.

As a result, the practice of nursery care is no longer recommended nor facilitated. However, most bassinets in U.S. hospitals are still designed for use by ambulatory nursery staff, rather than by mobility-impaired new mothers. These relics of nursery care restrict maternal access to their infants and introduce infants to increased risk of physical injury.

Bassinet tubs can tip under the weight of mothers' arms and the height of the tub walls can compromise infant handling. Often, new mothers are required to either substantially twist their bodies to access their infants or get up out of bed to reach them, despite being in immediate postpartum period and needing to heal. Such actions can cause new mothers to experience unnecessary frustration, pain, or even injury. This is especially critical to the one-third of U.S. women who deliver by cesarean section, as their limited ability to move and postpartum pain hinder timely and safe infant care, undermine breastfeeding, impede their own recovery, and contribute to risk of infant falls and suffocation.

The substantial difficulty maneuvering infants in and out of conventional bassinets, coupled with the pain and fatigue felt by new mothers, increase the risk of 1) infant drops, and 2) falling asleep with infants in unsafe arrangements.

To address these gaps in safe care, Couplet Care has developed a novel bassinet that allows mothers to position infants over their bed and handle the infants independently. This is the only bassinet model that gives mothers 100% access to their infant, without requiring the assistance of a second person for infant transfer or bassinet adjustment.

To ensure usability and safety, the Couplet Care Bassinet design incorporates (1) a lower tub wall with access points, making it easier for a mother to reach her infant, (2) adjustability features that allow for bassinet positioning over the mother, and (3) a design that secures the tub into the frame.

Building on the learnings from prototype use in a clinical setting during Phase I, Couplet Care proposes the following Phase II specific aims: 1) design Couplet Care Bassinet that is manufacturable and compliant with FDA regulations, 2) evaluate the impact of the Couplet Care Bassinet on maternal-infant patient outcomes in a powered RCT, 3) evaluate the usability and adoptability of the device from clinician and user perspectives.

This effort will give rise to a commercially viable bassinet that promotes safe mother-infant connection during rooming-in while reducing the risk of infant drops/falls and suffocation, maternal waking from unmet infant needs, and demands on nurses for assistance with non-medical needs.

Couplet Care

TO CONDUCT AND SUPPORT LABORATORY RESEARCH, CLINICAL TRIALS, AND STUDIES WITH PEOPLE THAT EXPLORE HEALTH PROCESSES. NICHD RESEARCHERS EXAMINE GROWTH AND DEVELOPMENT, BIOLOGIC AND REPRODUCTIVE FUNCTIONS, BEHAVIOR PATTERNS, AND POPULATION DYNAMICS TO PROTECT AND MAINTAIN THE HEALTH OF ALL PEOPLE. TO EXAMINE THE IMPACT OF DISABILITIES, DISEASES, AND DEFECTS ON THE LIVES OF INDIVIDUALS. WITH THIS INFORMATION, THE NICHD HOPES TO RESTORE, INCREASE, AND MAXIMIZE THE CAPABILITIES OF PEOPLE AFFECTED BY DISEASE AND INJURY. TO SPONSOR TRAINING PROGRAMS FOR SCIENTISTS, DOCTORS, AND RESEARCHERS TO ENSURE THAT NICHD RESEARCH CAN CONTINUE. BY TRAINING THESE PROFESSIONALS IN THE LATEST RESEARCH METHODS AND TECHNOLOGIES, THE NICHD WILL BE ABLE TO CONDUCT ITS RESEARCH AND MAKE HEALTH RESEARCH PROGRESS UNTIL ALL CHILDREN, ADULTS, FAMILIES, AND POPULATIONS ENJOY GOOD HEALTH. THE MISSION OF THE NICHD IS TO ENSURE THAT EVERY PERSON IS BORN HEALTHY AND WANTED, THAT WOMEN SUFFER NO HARMFUL EFFECTS FROM REPRODUCTIVE PROCESSES, AND THAT ALL CHILDREN HAVE THE CHANCE TO ACHIEVE THEIR FULL POTENTIAL FOR HEALTHY AND PRODUCTIVE LIVES, FREE FROM DISEASE OR DISABILITY, AND TO ENSURE THE HEALTH, PRODUCTIVITY, INDEPENDENCE, AND WELL-BEING OF ALL PEOPLE THROUGH OPTIMAL REHABILITATION.

93.865 - Child Health and Human Development Extramural Research

National Institute of Child Health and Human Development (NICHD) [HHS - NIH]

North Carolina United States

State-Wide

PHS 2022-2 Omnibus Solicitation of the NIH and CDC for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required) (PA-22-177)

Amendment Since initial award the End Date has been extended from 07/31/25 to 07/31/26 and the total obligations have increased 48% from $1,341,487 to $1,990,983.