taVNS-Paired Breastfeeding to Improve Breastfeeding at Discharge

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06417385
• Other study ID #: Pro00131771
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: February 1, 2025

Study information

• Verified date: May 2024
• Source: Medical University of South Carolina
• Contact: Haley Burdge
• Phone: 8432144089
• Email: burdge[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Weeks and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina Shawn Jenkins Children's Hospital	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adequate volume transfer during breastfeeding	Measured by pre- and post-feed weights (grams)	2 weeks
Primary	Infant's ability to sustain breastfeeding for a length of time	Average length of active feeding at the breast (minutes)	2 weeks
Primary	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
Primary	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	Frequency of breastfeeding assessed by study specific survey	Answers to related questions on taVNS-paired breastfeeding parental satisfaction survey	2 months
Secondary	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
Secondary	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