taVNS-Paired Breastfeeding to Improve Breastfeeding at Discharge

NCT ID: NCT06417385

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2026-02-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

taVNS treatment group

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

Group Type: EXPERIMENTAL

taVNS soterix device

Intervention Type: 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.

Interventions

taVNS soterix 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 35 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Haley Burdge

Medical/Dental Resident, Department of Pediatrics, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haley Burdge

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina Shawn Jenkins Children's Hospital

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Haley Burdge

Role: CONTACT

burdge@musc.edu

8432144089

Dorothea Jenkins

Role: CONTACT

jenkd@musc.edu

Facility Contacts

Haley Burdge, MD

Role: primary

burdge@musc.edu

8432144089

Dorothea Jenkins, MD

Role: backup

jenkd@musc.edu

Other Identifiers

Pro00131771

Identifier Type: -

Identifier Source: org_study_id