Combined Oral Motor Stimulation and Language on Preterm Infant Feeding

NARecruitingINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

July 1, 2025

Primary Completion Date

July 1, 2028

Study Completion Date

July 1, 2030

Conditions
Language DelayLanguage DevelopmentFeeding; Difficult, NewbornMother-Infant InteractionMaternal Behavior
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.

Trial Locations (1)

02905

RECRUITING

Women & Infants NICU, Providence

All Listed Sponsors
lead

Women and Infants Hospital of Rhode Island

OTHER

NCT05861531 - Combined Oral Motor Stimulation and Language on Preterm Infant Feeding | Biotech Hunter | Biotech Hunter