Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05861531
NA

Combined Oral Motor Stimulation and Language on Preterm Infant Feeding

Sponsor: Women and Infants Hospital of Rhode Island

View on ClinicalTrials.gov

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.

Official title: The Combined Association of an Oral Motor Stimulation and Language Intervention on Preterm Infant Feeding

Key Details

Gender

All

Age Range

23 Weeks - 30 Weeks

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2025-07-01

Completion Date

2030-07-01

Last Updated

2025-09-17

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Oromotor stimulation

This will begin around 33 weeks corrected, the day following the first NTrainer measurements. The oral stimulation program will be modeled after the protocol designed and studied for preterm infants and will be implemented for a goal of 10 consecutive days within a 14 day period. This includes 10 minutes of stroking the cheeks, lips, gums, and tongue, and the final 5 minutes consisting of mid tongue stroking, eliciting a suck with gloved finger, and sucking on a pacifier provided in the NICU. This will occur 15-30 minutes before a scheduled tube feeding when the infant is tolerating bolus enteral feeds of 120 ml/kg/day for at least 48 hours. This will occur behind a curtain to ensure blinding of staff and parents. Modifications will be made for infants that remain intubated and only 10 minutes of the stroking of the cheeks, lips, gums, and tongue will occur. Stimulation will cease if episodes of oxygen desaturation and/or apnea/bradycardia occur during the stimulation.

BEHAVIORAL

Reading curriculum

Written packets with biweekly lessons. The first two lessons include how to begin to read and talk to their baby. The second two lessons include reading or talking about the day using infant directed speech. The final two lessons include continuing to engage with the baby through interactive reading.

BEHAVIORAL

LENA recording

The LENA device provides 24 hours of language recordings placed inside an infant vest. The recordings are uploaded to a computer which analyzes total adult word counts, infant vocalizations, conversational turns, background noise, and silence.

BEHAVIORAL

LENA linguistic feedback

LENA recordings of adult word counts, infant vocalizations, and conversational turns will be provided in printed form after each recording with review of each recording and progress over time.

BEHAVIORAL

No oromotor stimulation

This will begin around 33 weeks corrected, the day following the first NTrainer measurements. The standard care group will not receive any stimulation but will have a study personnel present behind a curtain to ensure blinding of family, staff, and investigators. The study personnel will remain behind a curtain for 10-15 minutes prior to a feed for 10 days over a 14-day period beginning when the infant is tolerated 120 mL/kg/day for at least 48 hours.

Locations (1)

Women & Infants NICU

Providence, Rhode Island, United States