taVNS-Paired Breastfeeding to Improve Breastfeeding at Discharge

Not Applicable

Recruiting

• Conditions: Feeding; Difficult, Newborn; Premature Birth; Breastfeeding, Exclusive
• Interventions: Device: taVNS soterix device

• Registration Number: NCT06417385
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-01
• Study First Submitted: 2024-04-19
• Study First Submitted QC: 2024-05-12
• Study First Posted: 2024-05-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Primary Completion: 2026-02-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
taVNS treatment group	taVNS soterix device	All 10 infants will receive active taVNS during breastfeeding sessions. There is no randomization or blinding involved.

Primary Outcome Measures

Name	Time	Method
Adequate volume transfer during breastfeeding	2 weeks	Measured by pre- and post-feed weights (grams)
Infant's ability to sustain breastfeeding for a length of time	2 weeks	Average length of active feeding at the breast (minutes)
Targeted motor learning of skills involved in breastfeeding	2 weeks	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of South Carolina Shawn Jenkins Children's Hospital; 🇺🇸 Charleston, South Carolina, United States