NCT05861531

Combined Oral Motor Stimulation and Language on Preterm Infant Feeding

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Women and Infants Hospital of Rhode Island · Academic / Other
• Sex: All
• Age: 23 Weeks – 30 Weeks
• Healthy volunteers: Accepted

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.

Detailed description

This project aims to determine the effects of an oral motor stimulation combined with a reading curriculum vs an oral motor stimulation alone vs controls among preterm infants born 23-30 weeks gestation in the NICU. We hypothesize that the infants receiving an oral motor stimulation in conjunction with a reading curriculum will start oral feeding at an earlier age, have fewer days to full oral feeding, and fewer days in the NICU compared to infants receiving an oral motor stimulation and controls. We hypothesize that the infants receiving an oral motor stimulation in conjunction with a reading curriculum will have increased infant vocalizations, increased conversational turns, increased adult word counts, decreased maternal stress, decreased degree of post-traumatic stress post-discharge, improved receptive and expressive language development at 12 and 24 months, and improved parent reported behavioral outcomes at 24 months.

Conditions

• Language Delay
• Language Development
• Feeding; Difficult, Newborn
• Mother-Infant Interaction
• Maternal Behavior

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-01
• Primary completion: 2028-07-01
• Completion: 2030-07-01
• First posted: 2023-05-17
• Last updated: 2025-09-17

Locations

1 site across 1 country: United States