Globally, low breastfeeding rates account for nearly a million annual preventable deaths of women and children. Suboptimal breastfeeding in the United States is associated with $18B in healthcare costs and 3,340 annual premature deaths of women and children. Lack of support from healthcare providers is a primary reason for low breastfeeding rates. Physicians and nurses receive inadequate training in clinical lactation because existing educational products are not effective. Lactation educators use cloth and plastic baby dolls and sock puppets, which do not look or feel like an infant and cannot be used to teach how to differentiate between normal and abnormal suckling patterns and latching at the breast. High-fidelity (realistic) simulators promote higher learner engagement and are more likely to improve learning and patient outcomes. There are no high-fidelity newborn simulators for breastfeeding education. In this SBIR, LiquidGoldConcept, Inc. a breastfeeding education company in Michigan, will develop the first high-fidelity Newborn Oral Assessment and Latch Simulator (NORALSim) for breastfeeding education. The NORALSim will be compatible with the commercialized LiquidGoldConcept Lactation Simulation Model, a wearable, lactating breast model: the first high-fidelity breastfeeding mother-infant simulator. Educators will use the NORALSim and Lactation Simulation Model to teach healthcare students and practitioners how to assess the suck reflex, tongue movement, and oral cavity for anatomical and functional abnormalities relevant to breastfeeding, position and attach a newborn at the breast, and differentiate between normal and abnormal suckling and swallowing patterns. In Aim 1 of this Phase I SBIR, we will develop a NORALSim that looks and feels like a term newborn and has a remotely-operable jaw that simulates different suckling patterns and syncs with the sound of an infant swallowing. The NORALSims form and function will be evaluated for face and content validity by unbiased clinical lactation experts. In Aim 2, we will conduct a randomized, controlled, crossover trial with Johns Hopkins School of Nursing students to compare their level of engagement when using the NORALSim vs. low-fidelity newborn simulators in a simulated clinical encounter. We expect that the NORALSim will increase learner engagement, which will be associated with higher learner satisfaction, performance, and self-efficacy. In Phase II we will design custom components that simulate a newborns suck reflex. Pediatricians at the University of California, Davis will be randomized to the NORALSim or low-fidelity simulators. We expect that breastfeeding patients treated by pediatricians randomized to the NORALSim will report higher confidence in newborn positioning and attachment. Hospitals and health professional training programs in North America, Europe, and Asia are avid consumers of high-fidelity simulation. LiquidGoldConcept has already commercialized two high-fidelity breastfeeding simulation products and partnered with six international distributors.
Public Health Relevance Statement: Project Narrative Inadequate support from health providers leads to low breastfeeding rates and nearly a million annual infant and maternal deaths. There is an urgency to develop effective breastfeeding education tools for physicians and nurses. LiquidGoldConcept will develop a high-fidelity Newborn Oral Assessment and Latch Simulator complementary to the commercialized LiquidGoldConcept high-fidelity, wearable, lactating breast model to teach health providers infant positioning and attachment, signs of effective suckling, and newborn oral exam.
Project Terms: 3D Print; Anatomy; Asia; Breast; Breast Feeding; California; Cessation of life; Child; Clinical; clinical encounter; Clinical Skills; commercial application; Competence; Cross-Over Trials; Custom; Deglutition; design; Development; digital; Education; Educational process of instructing; Europe; Evaluation; Exclusive Breastfeeding; Face; Faculty; Feedback; Goals; Head; Health Care Costs; health care model; Health Personnel; Health Professional; Healthcare; Hospitals; improved; Infant; infant death; International; Jaw; Knowledge; Lactation; learning outcome; Legal patent; Maternal Mortality; Medical; Methods; Michigan; Modeling; models and simulation; Molds; Mothers; Movement; Newborn Infant; North America; Nurses; Nursing Students; Oral; Oral cavity; Outcome; Outcome Measure; Patient Care; Patient Self-Report; Patient-Focused Outcomes; Patients; Pattern; pediatrician; Perception; Performance; Phase; Physicians; Positioning Attribute; premature; preventable death; primary outcome; Problem Solving; programs; Puppet; Randomized; Reflex action; Reporting; Risk; Sales; satisfaction; School Nursing; Self Efficacy; Self-Examination; simulation; skills; Small Business Innovation Research Grant; sound; student participation; Students; sucking; suckling; Surveys; Techniques; technological innovation; Term Birth; Time; Tongue; tool; Toy; Training; Training Programs; United States; Universities; Variant; Weaning; Woman; Work
