Oral and non-oral sensorimotor interventions enhance oral feeding performance in preterm infants.
Sandra Fucile, Erika G Gisel, David H McFarland...
https://pubmed.ncbi.nlm.nih.gov/21707601Actively Recruiting
Phase Not Applicable
Age: 23Weeks - 30Weeks
All Genders
Healthy Volunteers
ID05861531
The Combined Association of an Oral Motor Stimulation and Language Intervention on Preterm Infant Feeding
Led by Women and Infants Hospital of Rhode Island · Updated on 2025-09-17
124
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of combining oral motor stimulation with a reading curriculum on feeding and language outcomes in preterm infants born between 23 and 30 weeks gestation in the neonatal intensive care unit (NICU). This randomized controlled trial aims to compare infants receiving oral motor stimulation plus a reading program, oral motor stimulation alone, and standard care to see if the combined approach leads to earlier oral feeding, shorter NICU stays, and better language development up to 24 months. The study includes three groups: one receiving oral motor stimulation combined with a language curriculum, another receiving only oral motor stimulation, and a control group receiving standard care without stimulation. Oral motor stimulation is provided for 10 days within a 14-day period starting around 33-34 weeks corrected age, involving gentle stroking and sucking exercises before feedings. Language exposure is monitored using a LENA device that records adult and infant vocalizations biweekly, with feedback provided to caregivers. The reading curriculum offers biweekly lessons to guide parents in engaging with their infants. Participants will undergo baseline and biweekly LENA recordings until 36 weeks corrected age, along with assessments including maternal stress and post-traumatic stress disorder screenings, child behavior checklists, and developmental tests at 12 and 24 months. Researchers will measure oral feeding milestones from birth to NICU discharge and track language and behavioral outcomes over two years. The trial includes ongoing feedback and monitoring to evaluate the impact of combined oral motor and language interventions on infant feeding and development.
CONDITIONS
Brief Title
Combined Oral Motor Stimulation and Language on Preterm Infant Feeding
Who Can Participate
Age: 23Weeks - 30Weeks
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Born between 23 and 30 weeks gestation
- English or Spanish speaking families
You will not qualify if you...
- Major congenital anomalies
- Surgical necrotizing enterocolitis
- Families not speaking English or Spanish
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Oral Motor Stimulation and Language Intervention
Duration - Up to 3 weeks (starting at 33-34 weeks postmenstrual age)
Participants receive oral motor stimulation for 10 days over a 14-day period starting around 33-34 weeks postmenstrual age, along with biweekly language recordings and feedback using the LENA device and a reading curriculum.
Biweekly LENA recording visits and 10 oral motor stimulation sessions over 2 weeks
Oral Motor Stimulation Alone
Duration - Up to 3 weeks (starting at 33-34 weeks postmenstrual age)
Participants receive oral motor stimulation for 10 days over a 14-day period starting around 33-34 weeks postmenstrual age, with biweekly language recordings and feedback using the LENA device.
Biweekly LENA recording visits and 10 oral motor stimulation sessions over 2 weeks
Standard Care Observation
Duration - Up to 3 weeks (starting at 33-34 weeks postmenstrual age)
Participants receive standard care without oral motor stimulation but have biweekly language recordings using the LENA device.
Biweekly LENA recording visits
Follow-up Assessments
Duration - Up to 24 months
Participants undergo assessments including maternal stress screening at 36 weeks corrected age, post-traumatic stress disorder screening at 7, 12, and 24 months, child behavior assessment at 24 months, and developmental testing at 12 and 24 months.
Scheduled visits at 36 weeks corrected age, and at 7, 12, and 24 months corrected age
Trial Site Locations
Total: 1 location
1
Women & Infants NICU
Providence, Rhode Island, United States, 02905
Actively Recruiting
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Research Team
J
Julia Mayne, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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Published Research Related To This Trial
Association between feeding difficulties and language delay in preterm infants using Bayley Scales of Infant Development-Third Edition.
Ira Adams-Chapman, Carla M Bann, Yvonne E Vaucher...
https://pubmed.ncbi.nlm.nih.gov/23582139Parent stress in the neonatal intensive care unit and the influence of parent and infant characteristics.
Linda Dudek-Shriber
https://pubmed.ncbi.nlm.nih.gov/15481778Modification of the Perinatal PTSD Questionnaire to enhance clinical utility.
J L Callahan, S E Borja, M T Hynan
https://pubmed.ncbi.nlm.nih.gov/16826190