Combining oral muscle exercises and bedside reading to help preterm babies feed and build language

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled study enrolls preterm infants born at 23–30 weeks in the NICU and randomizes them to combined oromotor stimulation plus a bedside reading curriculum, oromotor stimulation alone, or usual care. Interventions include daily oral muscle exercises, a structured reading curriculum delivered at the bedside, and continuous Language Environment Analysis (LENA) recordings with linguistic feedback for families. Primary clinical outcomes are time to start oral feeding, days to full oral feeds, and NICU length of stay, while developmental outcomes include infant vocalizations, conversational turns, adult word counts, and receptive/expressive language at 12 and 24 months. Maternal stress, post-traumatic stress symptoms, and parent-reported behavioral outcomes at 24 months are also tracked as secondary endpoints.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 23-30 weeks
* English and Spanish speaking

Exclusion Criteria:

* Major congenital anomalies
* Surgical necrotizing enterocolitis
* Non-English and Non-Spanish speaking

Where it's running

• Women & Infants NICU
  Providence, Rhode Island, United States Recruiting

Study contacts

• Study coordinator: Julia Mayne, MD
• Email: jmayne@wihri.org
• Phone: 4014307445

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.