Custom Accessories for Breastfeeding Success

Exclusive breastfeeding for the first six months is widely recommended by the medical community. Breastfed infants have lower risk of SIDS, severe lower respiratory disease, ear and gastrointestinal infections, leukemia, and diabetes than infants fed formula. Breastfeeding mothers benefit from reduced risk of cardiovascular disease, diabetes, and ovarian, breast, and endometrial cancer. Despite these benefits, only one in four infants is exclusively breastfed at six months due, in part, to lactation and human milk-pumping challenges. Many bottles, pacifiers, nipple shields, and pump parts (“Infant Feeding Accessories,” (IFA)) are marketed, but none are customized to the breastfeeding parent’s actual anatomy. The American Academy of Pediatrics and World Health Organization advise avoidance of artificial nipples for breastfed babies; however, these products are commonly used, and early avoidance of them can lead to increased stress for parents struggling to establish breastfeeding, and to bottle refusal by breastfed infants. The creation of IFAs customized to the lactating parent's anatomy, as contemplated in U.S. Patent No. 10,449,121 B2 and U.S. Patent Application No. 17/954,324,7 (“Customized Accessories” (CA)), could improve the fit of IFAs, improve milk flow, decrease pain for the lactating parent, eliminate nipple confusion, prolong breastfeeding, and support transition to direct breastfeeding for preterm infants. In Phase I of this project, UC Davis, in conjunction with CBEZ, LLC, will conduct foundational research to: (1) Characterize the critical design features of the CA and their related mobile health (mHealth) platform that would make them acceptable and feasible for lactating parents and their infants to use; and (2) Develop a preliminary catalog of prototype customized nipples and a process by which a scan or photos of a lactating parent’s nipple, areola, and surrounding breast tissue (“Nipple Image”) is matched with the most similar customized nipple in the catalog. The project will be managed by a CBEZ, LLC, a small business that consists of an engineer with more than 37 years of experience leading multi-disciplinary research projects; a patented inventor who is the inventor of U.S. Patent No. 10,449,121 B2; a project management consultant with experience managing multidisciplinary web user interface projects; and a team of machine learning specialists. UC Davis’ team consists of Dr. Laura Kair, a pediatrician who conducts clinical trials and qualitative research focused on overcoming breastfeeding barriers; Dr. Melissa Chen, an obstetrician/ gynecologist and clinical researcher who has expertise in conducting clinical research among breastfeeding women; and Steven Lucero, a biomedical engineer who is the Laboratory Manager of the Translating Engineering Advances to Medicine Lab, an advanced prototyping lab specializing in 3D scanning and additive manufacturing that includes anatomical models. After the successful completion of this project, the team will be well-positioned to further develop and produce CA, and to conduct additional research to determine efficacy of CA on breastfeeding success, thereby impacting maternal and child health across the lifecourse.