taVNS added to oral motor training for babies with severe swallowing trouble

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 interventional study examines the safety and feasibility of transcutaneous auricular vagus nerve stimulation (taVNS) combined with an oral sensorimotor program in infants with severe dysphagia. Participants receive taVNS twice daily during the three-week intervention alongside structured oromotor training, with outcomes measured before and after to assess swallowing mechanics, sucking proficiency, and functional feeding performance. The study focuses on infants 37 weeks or more gestational age who have significant swallowing impairment and limited oral feeding in the NICU. The approach aims to identify preliminary signals of benefit to guide larger trials, while monitoring safety in this vulnerable population. No efficacy conclusions will be drawn until data from a larger, powered study are available.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Infants ≥37 weeks post-menstrual age
* Diagnosed with dysphagia and significant sucking/swallowing impairment
* Limited oral feeding ability
* Admitted to NICU

Exclusion Criteria:

* Cardiomyopathy
* Unstable bradycardia
* Significant respiratory support requirement
* Absence of gag reflex
* Inability to manage secretions
* Infants of poorly controlled diabetic mothers

Where it's running

• Shawn Jenkins Children's Hospital
  Charleston, South Carolina, United States Recruiting

Study contacts

• Study coordinator: Heather C McGhee, PhD
• Email: mcghee@musc.edu
• Phone: 7708834902

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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.