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.