Back to Trials
NCT06417385NARecruitingAccepts Healthy Volunteers

taVNS-Paired Breastfeeding to Improve Breastfeeding at Discharge

Medical University of South Carolina

Start Date

2/1/2024

Completion Date

6/1/2027

Summary

Investigators aim to improve the skills of premature or sick term infants in breastfeeding by boosting motor learning with transcutaneous vagus nerve stimulation. Investigators will recruit 10 premature, ≥ 35 weeks gestational age, or convalescing sick term infants admitted to the NICU at MUSC to participate in this study. Infants will receive taVNS treatments once a day with breastfeeding's for up to 14 days. Before each treatment, the researcher will determine how much electrical stimulation is needed for the infant to feel a slight tingle without discomfort, and during daily treatment paired with breastfeeding the infant will continue to receive this level of electrical stimulation, coinciding with latching and sucking, repeated over the duration of the feed. Investigators will collect information about the pre- and post-feed weights, the length of time for each feed, and observations of latch, suck, and swallow techniques by the infant from parents and the lactation consultant. Investigators will also evaluate parental satisfaction associated with their infant's ability to breastfeed after taVNS by providing parental satisfaction surveys at the beginning, after 1 and 2 weeks, and at 3 months after the end of the study to assess infants' progress in and maintenance of breastfeeding abilities. If the pairing of breastfeeding with taVNS is able to result in improved outcomes of effective breastfeeding in infants in the neonatal intensive care units, this intervention could be further utilized by NICUs to increase the rate of premature and sick term infants who are successfully able to breastfeed at the time of discharge and maintain breast feeding longer after discharge. This would allow premature infants to acquire the many benefits of breastmilk as well as contribute towards the strengthening of the maternal-infant bond that breastfeeding has been shown to enhance.

Eligibility Criteria

Age Range: No minimum to No maximum

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.

Interventions

DEVICE

taVNS soterix device

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Premature BirthBreastfeeding, ExclusiveFeeding; Difficult, Newborn

Locations

Medical University of South Carolina Shawn Jenkins Children's Hospital

Charleston, South Carolina 29425

United States