Learning to Talk, Learning to Eat: A Randomized Controlled Trial to

Status Not yet recruiting

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

Clinical Trial Details

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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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Learning to Talk, Learning to Eat: A Randomized Controlled Trial to Improve NICU Oral Feeding and Language Outcomes

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms