Premature BirthNCT06417385
taVNS-Paired Breastfeeding to Improve Breastfeeding at Discharge
A study testing taVNS soterix device in people with Premature Birth and Breastfeeding, Exclusive, run by Medical University of South Carolina at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 35 weeks and olderHealthy volunteers can take part
- Conditions the study is for
- Premature Birth, Breastfeeding, Exclusive, Feeding; Difficult, Newborn
- What is being tested?
- taVNS soterix device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 weeks and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dorothea Jenkins contact
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina Shawn Jenkins Children's Hospital
Charleston, South Carolina, 29425
Haley Burdge, MD, 8432144089, burdge@musc.edu
Dorothea Jenkins, MD, jenkd@musc.edu
About this study
Official title: 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.
- Being tested
- taVNS soterix device
- Medical subject headings
- Premature Birth, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taVNS soterix deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| taVNS treatment group | Experimental | All 10 infants will receive active taVNS during breastfeeding sessions. There is no randomization or blinding involved. Receives: Device: taVNS soterix device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate volume transfer during breastfeeding
Measured by pre- and post-feed weights (grams)
Measured: 2 weeks
Infant's ability to sustain breastfeeding for a length of time
Average length of active feeding at the breast (minutes)
Measured: 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.
Measured: 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)
Measured: 2 weeks
Secondary outcomes (3)
Frequency of breastfeeding assessed by study specific survey
Answers to related questions on taVNS-paired breastfeeding parental satisfaction survey
Measured: 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
Measured: 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
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Feb 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haley Burdge, Medical University of South Carolina
- Investigators
- Haley Burdge, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06417385
- Sponsor's protocol ID
- Pro00131771
- Status last verified
- Feb 2026
- First submitted
- 19 Apr 2024
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)-Paired Breastfeeding to Improve Breastfeeding at Discharge
- ClinicalTrials.gov ID
- NCT06417385
- Acronym / sponsor ID
- Pro00131771
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| taVNS treatment group | Experimental | Device: taVNS soterix deviceAll 10 infants will receive active taVNS during breastfeeding sessions. There is no randomization or blinding involved. |
Who may qualify
- Ages
- 35 weeks and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| taVNS soterix deviceSoterix 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. | Device | taVNS treatment group |
Primary outcome
Adequate volume transfer during breastfeeding
Time frame: 2 weeks
Measured by pre- and post-feed weights (grams)
Infant's ability to sustain breastfeeding for a length of time
Time frame: 2 weeks
Average length of active feeding at the breast (minutes)
Targeted motor learning of skills involved in breastfeeding
Time frame: 2 weeks
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.
Targeted motor learning of skills involved in breastfeeding
Time frame: 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)
3 secondary outcomes
Frequency of breastfeeding assessed by study specific survey
Time frame: 2 months
Parent satisfaction with infant's ability to breastfeed assessed by study specific survey
Time frame: 2 months
Level of connectedness and social-emotional bond felt by mother towards infant assessed by study specific survey
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dorothea Jenkins contact
Haley Burdge principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing taVNS soterix device in people with Premature Birth and Breastfeeding, Exclusive, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haley Burdge (8432144089, burdge@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequate volume transfer during breastfeeding (time frame: 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.