Combining oral muscle exercises and bedside reading to help preterm babies feed and build language
The Combined Association of an Oral Motor Stimulation and Language Intervention on Preterm Infant Feeding
This project tests whether pairing gentle oral muscle exercises with bedside parent reading helps preterm infants (born 23–30 weeks) start oral feeding sooner and improve early language.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 23 Weeks to 30 Weeks |
| Sex | All |
| Sponsor | Women and Infants Hospital of Rhode Island Academic / other |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT05861531 on ClinicalTrials.gov |
What this trial studies
This randomized controlled study enrolls preterm infants born at 23–30 weeks in the NICU and randomizes them to combined oromotor stimulation plus a bedside reading curriculum, oromotor stimulation alone, or usual care. Interventions include daily oral muscle exercises, a structured reading curriculum delivered at the bedside, and continuous Language Environment Analysis (LENA) recordings with linguistic feedback for families. Primary clinical outcomes are time to start oral feeding, days to full oral feeds, and NICU length of stay, while developmental outcomes include infant vocalizations, conversational turns, adult word counts, and receptive/expressive language at 12 and 24 months. Maternal stress, post-traumatic stress symptoms, and parent-reported behavioral outcomes at 24 months are also tracked as secondary endpoints.
Who should consider this trial
Good fit: Ideal candidates are preterm infants born at 23–30 weeks gestation whose families speak English or Spanish and who do not have major congenital anomalies or surgical necrotizing enterocolitis.
Not a fit: Infants with major congenital anomalies, those requiring surgical necrotizing enterocolitis management, or families who do not speak English or Spanish are unlikely to benefit or be eligible for this protocol.
Why it matters
Potential benefit: If successful, the combined approach could shorten time to initial and full oral feeding, reduce NICU length of stay, and support better early language and developmental outcomes.
How similar studies have performed: Previous studies suggest oromotor stimulation can improve feeding and increased parent language exposure benefits early language, but combining these interventions in the NICU is relatively novel and not yet widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 23-30 weeks * English and Spanish speaking Exclusion Criteria: * Major congenital anomalies * Surgical necrotizing enterocolitis * Non-English and Non-Spanish speaking
Where this trial is running
Providence, Rhode Island
- Women & Infants NICU — Providence, Rhode Island, United States (Recruiting)
Study contacts
- Study coordinator: Julia Mayne, MD
- Email: jmayne@wihri.org
- Phone: 4014307445
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.