Assessment of the efficacy of a novel nipple designfor ease of feeding and naso-alveolar molding in infants with congenital unilateral cleft lip and palate.

Rationale   Cleft lip and palate is the most common congenital anomaly with incidence of two children per 1000 new born babies in Asia where feeding is an immediate concern which leads to malnutrition. To combat feeding issues, a novel feeder consisting of a nipple with lateral wings has been prepared to facilitate feeding and help in alveolar molding by keeping the tongue away from the defect.

 Novelty   This novel feeder matches the anatomy of the palate and bridges the palatal defect. The child can press the nipple against both the separated palatal shelves for expulsion of milk.

Objectives   To assess the efficacy and ease of care by using this nipple for feeding and alveolar molding of babies born with unilateral cleft lip and palate defects.

Methods   Participants, less than three week old,  will be a randomly allocated to intervention and control group.  The intervention group will be fed with the novel nipple which will act as a pacifier during other times (along with lip taping and nasal elevation). Those in control group will receive spoon feeding along with NAM appliance. Primary parameters like efficacy of feeding; parent’s experience on feeding; changes in the alveolar cleft and nasal anatomy and secondary parameters like weight, length; will be assessed for twenty weeks.

Expected Outcome   The present feeder will effectively ease the process of feeding, reduce the burden of care on the parents and enhance the growth parameters of unilateral cleft child. This nipple along with lip taping and nasal elevation will achieve naso-alveolar molding as well.