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Recruiting NCT05861531

NCT05861531 Combined Oral Motor Stimulation and Language on Preterm Infant Feeding

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Clinical Trial Summary
NCT ID NCT05861531
Status Recruiting
Phase
Sponsor Women and Infants Hospital of Rhode Island
Condition Language Delay
Study Type INTERVENTIONAL
Enrollment 124 participants
Start Date 2025-07-01
Primary Completion 2028-07-01

Eligibility & Interventions

Sex All sexes
Min Age 23 Weeks
Max Age 30 Weeks
Study Type INTERVENTIONAL
Interventions
Oromotor stimulationReading curriculumLENA recording

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 124 participants in total. It began in 2025-07-01 with a primary completion date of 2028-07-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

This is a randomized controlled trial to study an oromotor stimulation in combination with a reading curriculum in the NICU among preterm infants using oral muscle exercises, Language Environment Analysis (LENA) recordings, linguistic feedback, and a language curriculum to improve the neonatal inpatient oral feeding and language outcomes for preterm infants.

Eligibility Criteria

Inclusion Criteria: * 23-30 weeks * English and Spanish speaking Exclusion Criteria: * Major congenital anomalies * Surgical necrotizing enterocolitis * Non-English and Non-Spanish speaking

Contact & Investigator

Central Contact

Julia Mayne, MD

✉ jmayne@wihri.org

📞 4014307445

Frequently Asked Questions

Who can join the NCT05861531 clinical trial?

This trial is open to participants of all sexes, aged 23 Weeks or older, up to 30 Weeks, studying Language Delay. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05861531 currently recruiting?

Yes, NCT05861531 is actively recruiting participants. Contact the research team at jmayne@wihri.org for enrollment information.

Where is the NCT05861531 trial being conducted?

This trial is being conducted at Providence, United States.

Who is sponsoring the NCT05861531 clinical trial?

NCT05861531 is sponsored by Women and Infants Hospital of Rhode Island. The trial plans to enroll 124 participants.

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