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Search / Trial NCT06417385

taVNS-Paired Breastfeeding to Improve Breastfeeding at Discharge

Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · May 12, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new way to help premature and sick term infants learn to breastfeed better while they are in the neonatal intensive care unit (NICU). The researchers will use a method called transcutaneous vagus nerve stimulation (taVNS), which involves gentle electrical stimulation to help boost the infants' feeding skills. They will recruit 10 infants who are at least 35 weeks old and are safe to breastfeed, but who may be struggling to latch or suck effectively. These infants will receive daily taVNS treatments while breastfeeding for up to 14 days. The team will closely monitor how much milk the infants take, how long they feed, and how well they latch and suck.

Parents of the participating infants can expect to provide input about their experiences through surveys that will assess their satisfaction with their baby's breastfeeding progress at the start of the study, after one and two weeks, and three months later. This study hopes to find out if pairing breastfeeding with taVNS can improve breastfeeding success for these infants, which could lead to more premature and sick term babies being able to breastfeed effectively when they leave the hospital. This would not only ensure that these infants receive the many benefits of breast milk but also help strengthen the bond between mother and baby.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Infants ≥ 35 weeks post-menstrual age,
  • Clinically stable, without significant respiratory support,
  • Deemed safe to breastfeed by OT/SLP/lactation,
  • Maternal interest in breastfeeding,
  • Are not breastfeeding well despite the assistance of a lactation consultant.
  • Exclusion Criteria:
  • Cardiomyopathy,
  • Unstable bradycardia,
  • Significant respiratory support,
  • Absent maternal interest in breastfeeding, or infant or mother with contraindications to breastfeeding such as infantile galactosemia,
  • Maternal HIV without adequate viral suppression,
  • Maternal illicit drug use.

About Medical University Of South Carolina

The Medical University of South Carolina (MUSC) is a leading academic health center dedicated to advancing medical research and improving patient care through innovative clinical trials. With a strong emphasis on translational medicine, MUSC leverages its extensive resources and expertise to facilitate groundbreaking studies across various medical disciplines. The institution is committed to fostering collaboration among researchers, healthcare professionals, and patients, ensuring that cutting-edge discoveries translate into effective treatments. As a pioneer in health education and research, MUSC plays a vital role in shaping the future of medicine and enhancing health outcomes in the community and beyond.

Locations

Charleston, South Carolina, United States

Patients applied

0 patients applied

Trial Officials

Haley Burdge

Principal Investigator

Medical University of South Carolina

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported