Development of a Breast Feeding Appliance for Infants with Cleft Lip and Palate

DESCRIPTION (provided by applicant): Cleft Lip and Palate (CLP) is a relatively common birth defect with estimates of 1 in 500 births to 1 in 700 births. Annually, there are approximately 6000 infants born with CLP in the U.S and approximately 130,000 infants globally. Feeding of CLP infants is generally considered to be challenging. Breast-feeding has largely been considered to be near impossible or certainly impractical to perform, and as a result the infants are bottle-fed with modified nipples. Expressed milk is then used to allow for the transfer of the mother's milk, which is generally acknowledged as being highly superior to formula. Breast Feeding is an important but stressful, time consuming and energy intensive activity for CLP infants. Shape Change Technologies is proposing to develop a simple, modular and inexpensive appliance that would increase the efficiency and lower the stress and burden of breast feeding. The uniqueness of the proposed product lies in several areas: 1. its modular design allows for only one product to be developed for the CLP population, reducing tooling costs and ultimately keeping the cost per device as low as possible. 2. The use of a differentially stiff nipple allows for the device to be suitable for a wide variety of palate morphologies. 3. It would be the only product on the market that responds to this need. This research is part of an overall plan by this company to enhance breast feeding for both CLP infants and then premature infants. For CLP infants and family, stress reduction on both child and mother is especially important. The incidence of divorce with CLP infants after 1 year is over 50%, so the ability to enhance the nurturing aspect of breastfeeding will benefit the family.