A new synthetic patterned orocutaneous stimulation technique (NTrainer) has been shown previously to entrain the suck central pattern generator (sCPG) in human infants. The effectiveness of the NTrainer will be tested in a randomized trial among four groups of preterm infants. Three of the clinical populations selected are especially at risk for significant oromotor dysfunction and feeding difficulties, including babies with (1) moderate-severe history of respiratory distress syndrome (RDS), (2) chronic lung disease and/or bronchopulmonary dysplasia (CLD/BPD), and (3) infants with Down syndrome (DS). Preterm infants distributed among these groups with birth gestational ages between 26 and 32 weeks will be randomly assigned to experimental (Treatment w/NTrainer) and control (No Treatment sham stimulation) subgroups. The fourth group will consist of HEALTHY preterm infants. It is hypothesized that premature infants with a significant history of RDS, CLD/BPD, and Down syndrome will demonstrate significant reorganization and activation of the sCPG following NTrainer treatment. Primary outcome variables include daily measures of non-nutritive suck dynamics (NeoSuck), spatiotemporal index of the non-nutritive suck (STI NNS), ororhythmic motor behavior, NNS cycle period analysis, early feeding skills assessment, transition time from tube-to-oral feed, feeding efficiency, and length of hospital stay. A second major objective will include a comprehensive assessment of neurodevelopmental outcome at 3 years of age. The Bayley III Developmental Scales and a battery of standardized articulation, vocabulary, grammar, and speech-language probes will provide vital information on production and reception. These measures will assess the potential link between oromotor status in prematurity, effects of NTrainer stimulation, and neurodevelopmental outcome. Prematurity is the leading cause of developmental disabilities in children, including cerebral palsy, mental retardation, blindness, chronic lung problems, attention deficit, and speech/language disorders. Feeding competency is another challenging hurdle facing many premature babies, especially for those who have an extensive oxygen history associated with respiratory disease, neurologic insult, or certain genetic defects which impair oromotor development. The lengthy intubation procedures cost the baby precious sensory and motor experiences during a critical period of brain development for oromotor pattern generation. Accelerated development of oromotor skills using a novel method for delivering patterned orocutaneous stimulation to the oral sensorium will directly benefit this growing population of fragile infants, leading to enhanced suck skills, decreased transition time from gavage tube-to-oral feed, decreased length of hospitalization, and promote a more positive neurodevelopmental outcome.
Prematurity is rising at an alarming rate in the United States, associated with 1 in 8 live births. Prematurity occurs during a critical period of brain development and is the leading cause of developmental disabilities in children, including cerebral palsy, mental retardation, blindness, chronic lung problems, attention deficit, and speech/language disorders. Feeding competency is another challenging hurdle facing many premature babies who have respiratory disease, brain injury, or certain genetic defects which impair oral development. A new medical device known as the NTrainer will be tested in a randomized trial among 240 tube-fed premature infants in order to determine if a novel synthetic oral stimulation therapy can effectively accelerate development of suck and feeding skills, enhance brain development, decrease the length of hospitalization, and improve speech-language and motor skills measured at 3 years of age.
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