Sponsor:
Women and Infants Hospital of Rhode Island
Code:
NCT05861531
Conditions
Language Delay
Language Development
Feeding; Difficult, Newborn
Mother-Infant Interaction
Maternal Behavior
Eligibility Criteria
Sex: All
Age: 0
Healthy Volunteers: Accepted
Interventions
Oromotor stimulation
Reading curriculum
LENA recording
LENA linguistic feedback
No oromotor stimulation
Brief summary:
Conditions
Language Delay
Language Development
Feeding; Difficult, Newborn
Mother-Infant Interaction
Maternal Behavior
Study ID
NCT05861531
Start date
Jul 1, 2025
Status verified date
Jul, 2025
Completion date
Jul 1, 2030
Anticipated
Primary completion date
Jul 1, 2028
Anticipated
Eligibility Criteria
Sex: All
Age: 0
Healthy Volunteers: Accepted
Enrollment
124 participants
Anticipated
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary purpose
Prevention
Arms
experimental: Oral motor stimulation with language
active comparator: Oral motor stimulation
no intervention: Standard Care
Interventions
Oromotor stimulation
Reading curriculum
LENA recording
LENA linguistic feedback
No oromotor stimulation
Primary outcome measure
Central contacts
Locations
Women & Infants NICU
Recruiting
Providence, Rhode Island, United States, 02905
Contacts
Sponsor
Women and Infants Hospital of Rhode Island
Last update posted
Sep 17, 2025
Last verified
Jul, 2025
Keywords
Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Women and Infants Hospital of Rhode Island on 2025-09-17.