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/23582139/Actively Recruiting
Led by Women and Infants Hospital of Rhode Island · Updated on 2025-09-17
124
Participants Needed
1
Research Sites
104 weeks
Total Duration
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
Combined Oral Motor Stimulation and Language on Preterm Infant Feeding
J
Julia Mayne, MD
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Women and Infants Hospital of Rhode Island
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Oral motor stimulation plus language support | Oral motor stimulation alone | Standard care without stimulation |
|---|---|---|---|
| What it is | A behavioral regimen combining structured oral motor stimulation before tube feeds with language‑focused reading lessons, LENA recordings, and feedback | A behavioral regimen with structured oral motor stimulation before tube feeds, without language or recording components | Standard care control where no oromotor stimulation is provided, with personnel present behind a curtain for blinding |
| Role in trial | Experimental arm combining stimulation and language enrichment | Active comparator testing oral motor stimulation by itself | Control arm with usual care and no stimulation |
| Primary use | To test whether adding language‑based engagement enhances feeding outcomes in preterm infants | To evaluate the effect of oral motor stimulation on feeding development | Serves as baseline comparison for feeding outcomes with no additional stimulation |
| How it is given or performed | Oromotor stroking for up to 10 minutes before feeds, plus biweekly reading lessons, 24‑hour language recording via LENA and feedback | Oromotor stroking for up to 10 minutes before feeds under a curtain for blinding | No stimulation; personnel sits behind a curtain for equivalent duration to mimic attention |
| Evidence status | No results yet for this combined intervention | No published outcomes yet for this arm in this trial | No outcomes reported yet for standard care arm |
| Important risks | Not yet established; safety not yet reported | Not yet established; safety not yet reported | Not applicable as standard care |
| Important limitations | Trial results not yet available; comparison across arms unknown | Same—no available outcome data yet | Same limitation applies as no outcomes are yet reported |
| Patient impact | Not yet established from this trial | Not yet established from this trial | Would follow usual preterm infant progression; trial data not available |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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
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
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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https://pubmed.ncbi.nlm.nih.gov/16826190/Women and Infants Hospital of Rhode Island
Lead Sponsor