taVNS-Paired Breastfeeding to Improve Breastfeeding at Discharge

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)-Paired Breastfeeding to Improve Breastfeeding at Discharge

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.

Study Overview

• Status: Recruiting
• Conditions: Premature Birth; Feeding; Difficult, Newborn; Breastfeeding, Exclusive
• Intervention / Treatment: Device: taVNS soterix device

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haley Burdge; Phone Number: 8432144089; Email: burdge@musc.edu
• Study Contact Backup: Name: Dorothea Jenkins; Email: jenkd@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina Shawn Jenkins Children's Hospital
      • Contact: Dorothea Jenkins, MD; Email: jenkd@musc.edu
      • Contact: Haley Burdge, MD; Phone Number: 843-214-4089; Email: burdge@musc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: taVNS treatment group; All 10 infants will receive active taVNS during breastfeeding sessions. There is no randomization or blinding involved.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of breastfeeding assessed by study specific survey	Answers to related questions on taVNS-paired breastfeeding parental satisfaction survey	2 months
Parent satisfaction with infant's ability to breastfeed assessed by study specific survey	Answers to related questions on taVNS-paired breastfeeding parental satisfaction survey	2 months
Level of connectedness and social-emotional bond felt by mother towards infant assessed by study specific survey	Answers to related questions on taVNS-paired breastfeeding parental satisfaction survey	2 months

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Haley Burdge, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: April 19, 2024
• First Submitted That Met QC Criteria: May 12, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 12, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth
• Other Study ID Numbers: Pro00131771

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No