Oral Motor Stimulation + Language for Feeding Issues in Preterm Infants

Overseen By Julia Mayne, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Women and Infants Hospital of Rhode Island

Disqualifiers: Major congenital anomalies, Surgical necrotizing enterocolitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 10 weeks

124 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach for preterm infants in the NICU to enhance feeding and language skills. It combines oral muscle exercises (oromotor stimulation) with language recordings and feedback (LENA recording and LENA linguistic feedback) to determine if these methods yield better results than standard care. The trial includes three groups: one using both muscle exercises and language tools, one using only the exercises, and a standard care group. The study seeks infants born between 23 and 30 weeks who can be around English or Spanish speakers. Infants fitting this profile could help researchers discover better ways to support early development in preterm infants. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could significantly advance neonatal care.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this protocol is safe for preterm infants?

Research has shown that the oral exercises used in this trial are generally safe for premature babies. These exercises can enhance feeding skills and enable babies to begin feeding independently sooner. No serious side effects have been reported from these exercises.

The trial also includes a language component, using LENA recordings and a reading program, which is considered safe. These activities aim to enrich the baby's language environment and have demonstrated benefits without causing harm. Overall, the treatments in this trial are well-tolerated and have been safely used in similar studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative approaches to help preterm infants with feeding issues. Unlike traditional care that often focuses on basic nutritional support, this trial examines the impact of combining oral motor stimulation with language exposure. This approach aims to enhance feeding skills by integrating speech development techniques, offering a more holistic method to address both feeding and early language needs. The use of LENA technology to provide detailed linguistic feedback is a unique feature that could offer deeper insights into infant development. By investigating these methods, researchers hope to advance our understanding of how early interventions can improve long-term outcomes for preterm infants.

What evidence suggests that this trial's treatments could be effective for feeding issues in preterm infants?

Research shows that exercises for the mouth and face can help preterm babies learn to eat better. In this trial, some participants will receive oral motor stimulation, which helps babies transition from tube feeding to eating by mouth. These exercises also enable babies to start eating independently sooner and can lead to shorter hospital stays. Another group in this trial will receive oral motor stimulation combined with language activities, which might also support better language development. Overall, these methods have been linked to better weight gain and improved eating skills in preterm babies. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for preterm infants born between 22-30 weeks. It's designed to help with feeding and language development issues that can happen because they were born early. Parents who speak English or Spanish can participate.

Inclusion Criteria

22-30 weeks

I can speak English or Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Obtain baseline LENA recording and review language curriculum

1 week

1 visit (in-person)

Treatment

Oral motor stimulation and language intervention with biweekly LENA recordings

10 weeks

Biweekly visits (in-person)

Follow-up

Participants are monitored for developmental outcomes and maternal stress

24 months

Periodic assessments at 7, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• LENA linguistic feedback
• LENA recording
• No oromotor stimulation
• Oromotor stimulation
• Reading curriculum

Trial Overview The study tests if special mouth exercises combined with a reading program in the NICU can improve how well these babies feed and learn language. Some will get this combo treatment, while others won't, to see which works better.

How Is the Trial Designed?

Group I: Oral motor stimulation with language Experimental Treatment 4 Interventions

1\. Obtain baseline LENA recording 2. Review language curriculum and provide LENA linguistic feedback 3. LENA recording every 2 weeks until 36 weeks corrected 4. Review age-appropriate language curriculum and provide LENA linguistic feedback from prior weeks 5. When reaches 33-34 weeks postmenstrual age and medically stable, occupational therapists will conduct 10-15 minute oral motor stimulation prior to a feeding time for 10 total days over a 2 week period 6. Final LENA feedback and PTSD screen Assessments: 1. PSS:NICU at 36 weeks corrected 2. PPQ screen at 7, 12, and 24 months corrected 3. Child Behavior Checklist at 24 months corrected 4. Bayley Scales of Infant and Toddler Development at 12 and 24 months

Group II: Oral motor stimulation Active Control 4 Interventions

1\. Obtain baseline LENA recording 2. LENA recording every 2 weeks until 36 weeks corrected 3. When reaches 33-34 weeks postmenstrual age and medically stable, occupational therapists will conduct 10-15 minute oral motor stimulation prior to a feeding time for 10 total days over a 2 week period. 4. Final LENA feedback and PTSD screen. Assessments: 1. PSS:NICU at 36 weeks corrected 2. PPQ screen at 7, 12, and 24 months corrected 3. Child Behavior Checklist at 24 months corrected 4. Bayley Scales of Infant and Toddler Development at 12 and 24 months

Group III: Standard Care Active Control 1 Intervention

1\. Obtain baseline LENA recording 2. LENA recording every 2 weeks until 36 weeks corrected 3. 6. Final LENA feedback and PTSD screen Assessments: 1. PSS:NICU at 36 weeks corrected 2. PPQ screen at 7, 12, and 24 months corrected 3. Child Behavior Checklist at 24 months corrected 4. Bayley Scales of Infant and Toddler Development at 12 and 24 months

Who Is Running the Clinical Trial?

Women and Infants Hospital of Rhode Island

Lead Sponsor

Trials

119

Recruited

59,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10600621/

Evaluation of the Effect of Oral Motor Stimulation Exercises on ... The results of this study support the benefit of OMS exercises in improving preterm infants' feeding skills before the transition from gavage feeding to oral ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0378378225001926

Effectiveness of an oral-motor intervention for premature ... Oral stimulation with breast milk improved feeding quality in preterm infants. · Maternal-led protocol was feasible and well-accepted by NICU ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11349818/

The effectiveness of oral motor interventions on the weight ... The findings revealed a significant decrease in oral feeding time and a significant increase in weight variation percentage in the intervention ...

4. journals.lww.com journals.lww.com/jsci/fulltext/2025/01000/effectiveness_of_oral_stimulation_on_feeding.13.aspx

Effectiveness of Oral Stimulation on Feeding Performance... In the pretest, the majority of preterm babies, 32 (42.8%), exhibited average feeding performance, while 28 (100%) demonstrated poor feeding performance. In ...

5. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08131-8

The effect of oral motor intervention with different initiation ... Recent studies reveal that OMIs can improve the oral motor function and oral feeding performance of preterm infants. The concept of OMIs, as ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8700416/

Feeding Problems and Long-Term Outcomes in Preterm ... The adjusted relative risk for total feeding problems was 1.57, refusal/picky eating was 1.53, and oral motor problems was 1.62.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1355184118301315

Oral feeding readiness and premature infant outcomes Preterm infants who demonstrated greater oral feeding readiness achieved full oral feeding sooner (P < 0.0001) and were discharged earlier from the hospital (P ...

8. tandfonline.com tandfonline.com/doi/full/10.1080/01942638.2025.2552136

Full article: Feeding Therapy and its Relationship to Timing ... Early initiation of feeding therapy may help expedite IOF. Timely referrals can support oral motor development and improve feeding outcomes in preterm infants.