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Clinical Trial Summary

This is a randomized controlled trial to study an oromotor stimulation in combination with a reading curriculum in the NICU among preterm infants using oral muscle exercises, Language Environment Analysis (LENA) recordings, linguistic feedback, and a language curriculum to improve the neonatal inpatient oral feeding and language outcomes for preterm infants.


Clinical Trial Description

This project aims to examine how an intervention involving a 10-day oromotor stimulation in combination with a reading curriculum in the NICU can impact preterm infant oral feeding development and examine the additional impact on language development. Investigators plan to determine the effects of an oromotor stimulation beginning at 33 weeks corrected on preterm infants, born between 22-30 weeks in the Women & Infants NICU, as measured by the days to initiate oral feeding, days to complete oral feeding, hospital duration, and NTrainer Pacifier System measures. Infants randomized to standard care without oromotor stimulation will receive the reading curriculum as well. Secondary outcomes will include LENA (Language Environment Analysis) recordings measuring adult word count, infant vocalizations, conversational turns through audio recording obtained biweekly until 36 weeks corrected. Additionally, investigators aim to determine the effect of an intervention of oromotor stimulation with reading on maternal stress and perceived well-being in the NICU through a validated questionnaire completed prior to infant discharge and at the 1, 3, 7, and 12 month follow up visits. Final outcomes include examination of the long-term effect of inpatient oromotor stimulation and shared reading education on infant receptive and expressive language development at 12 and 24 months. Investigators hope this research will contribute to the growing research supporting the connection between oral feeding and language development in preterm infants and its impact on maternal-infant well-being. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05861531
Study type Interventional
Source Women and Infants Hospital of Rhode Island
Contact Julia Mayne, MD
Phone 4014307445
Email jmayne@wihri.org
Status Not yet recruiting
Phase N/A
Start date June 1, 2023
Completion date June 1, 2028

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