taVNS-Paired Breastfeeding to Improve Breastfeeding at Discharge

NCT06417385 | Recruiting FDA Device

• 1 other identifier: Pro00131771
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Premature Birth; Breastfeeding, Exclusive; Feeding; Difficult, Newborn

Outcome Measures

Primary Outcomes (4)

• Adequate volume transfer during breastfeeding

  Measured by pre- and post-feed weights (grams)

  2 weeks

• Infant's ability to sustain breastfeeding for a length of time

  Average length of active feeding at the breast (minutes)

  2 weeks

• Targeted motor learning of skills involved in breastfeeding

  Demonstration of successful latch, suck, and swallow techniques by the infant per LATCH scoring (L= latch, A= audible swallowing, T= type of nipple (inverted, flat, everted after stimulation), C= Comfort of mother during feed, H= Hold/positioning of infant), scoring 0-10 (2 points per question) with 10 being the highest and optimal score.

  2 weeks

• Targeted motor learning of skills involved in breastfeeding

  Demonstration of successful latch, suck, and swallow techniques by the infant by study personnel descriptions (Only lactation consultants are trained to obtain LATCH scores, thus when no lactation consultant is present, study personnel will simply describe infant's demonstrated skills during the session without a specific measurement tool)

  2 weeks

Secondary Outcomes (3)

• Frequency of breastfeeding assessed by study specific survey

  2 months

• Parent satisfaction with infant's ability to breastfeed assessed by study specific survey

  2 months

• Level of connectedness and social-emotional bond felt by mother towards infant assessed by study specific survey

  2 months

Study Arms (1)

taVNS treatment group

EXPERIMENTAL

All 10 infants will receive active taVNS during breastfeeding sessions. There is no randomization or blinding involved.

Device: taVNS soterix device

Interventions

taVNS soterix device DEVICE

Soterix is a custom modified, FDA-cleared electrical stimulator that meets the criteria of the FDA for investigational use. Neoleads will be placed in order to deliver electrical stimulation using microcurrent (\<2.5mA) with breastfeeding, on with sucking and swallowing and off with rest for 5 feeds per week for 2 weeks.

taVNS treatment group

Eligibility Criteria

• Age: 35 Weeks+
• Gender Eligibility Details: The study population will include preterm infants at ≥ 35 weeks post-menstrual age or term infants requiring NICU admission due to medical illness. The study population will also include the infants' mothers who will participate in daily breastfeeding sessions and complete parental satisfaction surveys.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina Shawn Jenkins Children's Hospital

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Premature Birth; Breast Feeding

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Feeding Behavior; Behavior

Study Officials

• Haley Burdge

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haley Burdge

CONTACT

8432144089; burdge@musc.edu

Dorothea Jenkins

CONTACT

jenkd@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical/Dental Resident, Department of Pediatrics, Principal Investigator

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: May 16, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

US (1)