CompletedEarly Phase 1

taVNS Paired With Bottle Feeding in Infants Failing Oral Feeds

United States35 participantsStarted 2017-10-01

Plain-language summary

Oromotor dysfunction and poor feeding is common after premature birth and hypoxic ischemic encephalopathy (HIE). Pairing vagus nerve stimulation (VNS) with motor activity accelerates functional improvements after stroke. This study is designed to investigate whether transcutaneous auricular VNS (taVNS) paired with oromotor rehabilitation is tolerable, safe, and facilitates motor learning in infants who have failed oral feeding.

Who can participate

Age range3 Weeks – 5 Months

SexALL

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Inclusion criteria

✓. Premature at birth and attempting oral feeds for at least 3 weeks or
✓. Infants who are neart-term or term at birth, with significant medical issues that have precluded oral feeding, such as hypoxic ischemic encephalopathy (HIE), and attempting oral feeds for at least 2 weeks.

What they're measuring

Number of Infants Who Took All Feeds by Mouth (Responders)

Timeframe: 3 weeks

ml/kg/d Increase Over 7d During taVNS

Timeframe: 7 days

Neuroplasticity as Measured by the Change in White Matter Tract Integrity Via Fractional Anisotropy

Timeframe: change from baseline to week 3

Trial details

NCT IDNCT04643808

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-01

Results submitted2023-07-27

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