Development of the Couplet Care Bassinet to support safe implementation of skin-to-skin contact and rooming-in on postnatal units

Trig, Llc, Chapel Hill NC

Investigators

Abstract

PIs Hagler and Tully Development of the Couplet Care BassinetTM to support safe implementation of skin-to-skin contact and rooming-in on postnatal units. Abstract There is a striking lack of innovation around the maternity care environment, spanning decades. ?Couplet Care BassinetTM? development will establish a commercial product to promote breastfeeding, enhance safety for infants, and reduce undue strain on new mothers and their postnatal unit healthcare providers. The purpose of developing a new bassinet for postnatal units is to better enable maternal access to their infants, to advance implementation of Steps 4 and 7 of the Ten Steps to Successful Breastfeeding, skin-to-skin contact and continuous rooming-in. Visual and physical connection while women and their newborns ?room-in? at birthing facilities is important for maternal-infant health outcomes and infant mortality. To improve the patient experience and enable breastfeeding, reduce the risk of infant suffocation and falls, and reduce excess burden on nursing staff, we developed the Couplet Care BassinetTM prototype. Globally, most existing clinical bassinets consist of an unsecured acrylic tub on a wheeled cart. These devices were created for nurses transporting and caring for infants in a nursery, rather than mothers reaching their infants within a postnatal unit room. Continuous mother-infant rooming-in is now the standard of healthcare; however, bassinets in most birthing facilities in the U.S. and internationally increase risk for mothers and infants. The American Academy of Pediatrics clinical report, Safe Sleep and Skin-to-Skin Care in the Neonatal Period for Healthy Term Newborns, cited PI Tully?s work with a basic model of infant bassinets as promising for enhancing the maternity environment. Current bassinets require mothers to either substantially twist their bodies to access their infants or get up out of bed to reach them, thereby exposing new mothers to unnecessary pain or even to post-cesarean injury. Constraints conveyed by existing designs also place practical burdens and emotional strain on healthcare staff. Providers may be summoned to postnatal unit rooms for non-medical reasons, such as infant diaper changes, due to mothers? limited mobility in relation to the distance and high walls of existing bassinets. Infant risk is subsequently increased from newborns being in the maternity bed or on chairs while the adult is asleep, instead of placed back into the bassinet. This coping strategy while rooming-in reflects lack of human-centered design in the maternity environment and contributes to infant falls, suffocation, and risk of Sudden Unexpected Postnatal Collapse (SUPC). Hospital administrators are seeking bassinets offer better accommodation for patients, which may also reduce liability costs. The Couplet Care BassinetTM developed by PI Hagler and Trig Innovation seeks to remedy hazards through more ergonomic access to the infant, greater range of potential for bassinet positioning, and safety features new to the industry. The innovation is expected to reduce the risk for tragic, adverse events by providing a secure and accessible infant sleeping location. In Phase I we will (1) collaborate with healthcare providers and national-level maternity care leaders to enhance the medical device design such as improving technology around the side-walls; (2) conduct safety testing and submit the results for FDA approval; and (3) evaluate the feasibility of the Couplet Care BassinetTM through pilot work at two Baby Friendly Hospital Initiative designated sites. The objective is to create a product to better support women becoming mothers while enabling safer infant care practices.