Document text
Principal Investigator: Stacie McEntyre
Organization: COUPLET CARE, LLC
Fiscal Year: 2024
Award: $649,496
Funding agency: Eunice Kennedy Shriver National Institute of Child Health and Human Development
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.
Terms: <0-4 weeks old><21+ years old><Abdominal Delivery><Address><Adopted><Adult><Adult Human><Asphyxia><Beds><Birth><Breast Feeding><Breast fed><Breastfed><Breastfeeding><C section><Caring><Certification><Cesarean><Cesarean section><Client satisfaction><Clinical><Contracting Opportunities><Contracts><Coping Skills><Coupled><Data><Decline in mobility><Decrease in mobility><Decreased mobility><Development><Devices><Diminished mobility><Documentation><Drops><Electronic Health Record><Ensure><Environment><Event><Exposure to><Fatigue><Feedback><Frustration><Fullterm Birth><Health Care Providers><Health Care Team><Health Personnel><Healthcare Providers><Healthcare Team><Healthcare worker><Height><Hospital Administrators><Hospital Admission><Hospitalization><Hospitals><Hour><Iatrogenesis><Infant><Infant Care><Injury><Instruction><International><Interview><Lack of Energy><Learning><Length of Stay><Manufacturer><Medical><Medical Care Team><Medical Device><Medical center><Methods><Midwife><Mobility decline><Mobility impairment><Modeling><Mothers><Newborn Infant><Newborns><Number of Days in Hospital><Nurses><Outcome><Pain><Painful><Parents><Participant><Parturition><Patient Satisfaction><Patient outcome><Patient-Centered Outcomes><Patient-Focused Outcomes><Patients><Persons><Phase><Position><Positioning Attribute><Postpartum Period><Procedures><Process><Protocol><Protocols documentation><Questionnaires><Recommendation><Recovery><Reduced mobility><Reduction in mobility><Regulation><Reporting><Risk><Risk Reduction><Safety><Secure><Site><Skin><Sleep><Suffocation><Survey Instrument><Surveys><System><Term Birth><Testing><UNICEF><Update><Vagina><Weight><Woman><Work><World Health Organization><adulthood><arm><asphyxiation><baby care><coping strategy><design><designing><developmental><electronic health care record><electronic health medical record><electronic health plan record><electronic health registry><electronic medical health record><emotional trauma><experience><falls><full-term birth><fullterm newborn><healing><health care personnel><health care worker><health provider><health workforce><healthcare personnel><hospital bed><hospital care><hospital days><hospital length of stay><hospital stay><iatrogenic><iatrogenically><iatrogenicity><improved><infant health care><infant healthcare><injuries><innovate><innovation><innovative><licit opioid><manufacture><manufacturing process><medical personnel><member><mortality><newborn care><newborn child><newborn children><next generation><novel><nurse><operation><operations><opiate medication><opioid medication><parent><patient oriented outcomes><post-partum><postnatal><prescribed opiate><prescribed opioid><prescription opiate><prescription opioid><prototype><reduce risk><reduce risks><reduce that risk><reduce the risk><reduce these risks><reduces risk><reduces the risk><reducing risk><reducing the risk><risk-reducing><sleep pattern><standard of care><term newborn><treatment provider><usability><weights>