Quantitation of Oral-Motor Function in Infants

DESCRIPTION (provided by applicant): Background: Feeding problems are common in infants occurring in over 50% of those with prematurity, oropharngyeal dysfunction, or central nervous system injury [that may manifest later as cerebral palsy]. They can lead to poor growth, failure-to-thrive, recurrent hospitalization and present major diagnostic and management challenges. The most severe [>1:1000] require extensive evaluations; but apart from X-ray or bariatric studies, the clinical tools are visual and qualitative that still can leave unresolved questions. The Orometer is a novel device that attaches to a normal infant feeding bottle, designed to quantify nutritive sucking by infants with intuitive graphical output that can be shared and exchanged, facilitating professional consultations. No comparable instrument is available. In a phase I SBIR study, we showed successful results in testing a small cohort of normal infants. Hypothesis: It is possible to quantify and characterize such feeding problems even before an underlying etiology may be manifest. Such information would be of clinical value. Specific Aim: To conduct a clinical trial of the Orometer in 200 normal full term, and 200 potentially abnormal infants to establish basic orometric parameters in both normal and infants at risk. Long Term Plan: To develop the Orometer for routine clinical evaluation of feeding problems in infants. To license the Orometer to a manufacturer for final product development and sale. Study design: Test 200 normal full-term infants twice in the first 6 months to determine if the maturational changes occurring at that time can be detected and quantified. Test another 200 infants: 30 normal preterm infants twice in the first 3 months, and 170 others with, or at risk of having, feeding problems or delayed development, at referral and again at one year to determine whether their records differ from the normal patterns, and whether the initial study could identify correctly those infants with later developmental problems. Relevance: If successful, the Orometer would be useful in staging feeding, and thus expedite discharge of high-risk infants from NICUs. It would also be of prognostic and therapeutic value for infants with oral-motor dysfunction, including those with undiagnosed neurodevelopmental difficulties, or those destined to manifest cerebral palsy later. Early recognition of specific feeding problems should lead to earlier and better feeding strategies thus leading to earlier discharge and to better treatment of infants with long term disabilities. Commercial Potential: Potential sales to NICUs, developmental clinics, feeding specialists and pediatricians are projected in the 3000-8000/5years range.