Studio Hagler LLC — Department of Health and Human Services SBIR Phase I: NICHD

Description

PIs Hagler and Tully Development of the Couplet Care BassinetTM to support safe implementation ofskin to skin contact and rooming in on postnatal unitsAbstract There is a striking lack of innovation around the maternity care environmentspanning decadesCouplet Care BassinetTMdevelopment will establish a commercial product to promote breastfeedingenhance safety for infantsand reduce undue strain on new mothers and their postnatal unit healthcare providersThe purpose of developing a new bassinet for postnatal units is to better enable maternal access to their infantsto advance implementation of Stepsandof the Ten Steps to Successful Breastfeedingskin to skin contact and continuous rooming inVisual and physical connection while women and their newbornsroom inat birthing facilities is important for maternal infant health outcomes and infant mortalityTo improve the patient experience and enable breastfeedingreduce the risk of infant suffocation and fallsand reduce excess burden on nursing staffwe developed the Couplet Care BassinetTM prototypeGloballymost existing clinical bassinets consist of an unsecured acrylic tub on a wheeled cartThese devices were created for nurses transporting and caring for infants in a nurseryrather than mothers reaching their infants within a postnatal unit roomContinuous mother infant rooming in is now the standard of healthcarehoweverbassinets in most birthing facilities in the U Sand internationally increase risk for mothers and infantsThe American Academy of Pediatrics clinical reportSafe Sleep and Skin to Skin Care in the Neonatal Period for Healthy Term Newbornscited PI Tully s work with a basic model of infant bassinets as promising for enhancing the maternity environmentCurrent bassinets require mothers to either substantially twist their bodies to access their infants or get up out of bed to reach themthereby exposing new mothers to unnecessary pain or even to post cesarean injuryConstraints conveyed by existing designs also place practical burdens and emotional strain on healthcare staffProviders may be summoned to postnatal unit rooms for non medical reasonssuch as infant diaper changesdue to motherslimited mobility in relation to the distance and high walls of existing bassinetsInfant risk is subsequently increased from newborns being in the maternity bed or on chairs while the adult is asleepinstead of placed back into the bassinetThis coping strategy while rooming in reflects lack of human centered design in the maternity environment and contributes to infant fallssuffocationand risk of Sudden Unexpected Postnatal CollapseSUPCHospital administrators are seeking bassinets offer better accommodation for patientswhich may also reduce liability costsThe Couplet Care BassinetTM developed by PI Hagler and Trig Innovation seeks to remedy hazards through more ergonomic access to the infantgreater range of potential for bassinet positioningand safety features new to the industryThe innovation is expected to reduce the risk for tragicadverse events by providing a secure and accessible infant sleeping locationIn Phase I we willcollaborate with healthcare providers and national level maternity care leaders to enhance the medical device design such as improving technology around the side wallsconduct safety testing and submit the results for FDA approvalandevaluate the feasibility of the Couplet Care BassinetTM through pilot work at two Baby Friendly Hospital Initiative designated sitesThe objective is to create a product to better support women becoming mothers while enabling safer infant care practices PIs Hagler and Tully Development of the Couplet Care BassinetTM to support safe implementation ofskin to skin contact and rooming in on postnatal unitsProject Narrative Across the United Statesnew mothers are exposed to unnecessary frustrationpain or even injury because the infant bassinets on postnatal units are designed for use while standingnot from the maternity bed while rooming inImpeded maternal access to their newborns due to lack of human centered design is especially troublesome after cesarean section deliveryThese barriers undermine breastfeeding and increase infant risk of falls and accidental suffocationTrig Innovation is partnering with UNC Chapel Hill investigators and stakeholders to develop the Couplet Care BassinetTM to address the long standing shortcomings of existing hospital infant bassinets and offer new safety features