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BabySTrong II taVNS Feeding Trial

RecruitingPhase 2, Phase 3Ages 39 Weeks - 54 WeeksAllMedical University of South Carolina
NCT07049952 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The long-term goal of this project is to develop a therapy to assist pre-term and term infants with brain injury overcome difficulties in learning to feed so that infants may be discharged home with their families and avoid the burdens of of a gastrostomy tube (G-tube) or prolonged home nasogastric feeding. Few other therapies exist for infants who are not making progress with feeding volumes at term age. To tackle this problem, we took the novel approach of pairing non-invasive nerve stimulation of the vagus nerve at the ear (taVNS) stimulation with the motor skills of feeding. In our pilot studies, 54% (19 out of 35) infants with feeding delays whose families were in discussions for G-tube placement, reached full oral feeds within 2 weeks, and infants who did not reach full feeds still improved their daily oral feeding volumes. Infants who got to full feeds showed stronger and more co

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📋 Eligibility rules (as published)
Inclusion Criteria: * infants \>39 weeks PMA making minimal progress in oral feeds * trying to learn feeding for at least 2wks if beginning feeds at term (\>37wks PMA), and 4wks if beginning feeds \<36wks PMA, * may po every feed without volume limitations by therapists Exclusion Criteria: * cardiomyopathy * unstable apnea/bradycardia * significant respiratory support (CPAP/ Vapotherm) * unrepaired major congenital anomalies that affect safe po feeding or impose volume restrictions * congenital syndromes unlikely to orally feed
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What it tests

  • taVNS
  • NAC and taVNS
  • inactive taVNS
  • sterile water and inactive taVNS
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Where

1 site
Shawn Jenkins Children's Hospital, Medical University of South Carolina
Charleston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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