## Protocol Section
### Identification Module
**NCT ID:** NCT06417385

**Brief Title:** taVNS-Paired Breastfeeding to Improve Breastfeeding at Discharge

**Official Title:** Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)-Paired Breastfeeding to Improve Breastfeeding at Discharge

#### Organization Study ID Info
**ID:** Pro00131771
#### Organization
**Class:** OTHER
**Full Name:** Medical University of South Carolina
### Status Module
#### Completion Date
**Date:** 2025-02-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-12

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-02-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-02-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-19
**Study First Submit QC Date:** 2024-05-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Medical University of South Carolina

#### Responsible Party

**Investigator Affiliation:** Medical University of South Carolina

**Investigator Full Name:** Haley Burdge

**Investigator Title:** Medical/Dental Resident, Department of Pediatrics, Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Premature Birth

- Breastfeeding, Exclusive

- Feeding; Difficult, Newborn

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 10

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Device: taVNS soterix device

**Label:** taVNS treatment group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- taVNS treatment group

**Description:** 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.

**Name:** taVNS soterix device

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Measured by pre- and post-feed weights (grams)

**Measure:** Adequate volume transfer during breastfeeding

**Time Frame:** 2 weeks

**Description:** Average length of active feeding at the breast (minutes)

**Measure:** Infant's ability to sustain breastfeeding for a length of time

**Time Frame:** 2 weeks

**Description:** 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.

**Measure:** Targeted motor learning of skills involved in breastfeeding

**Time Frame:** 2 weeks

**Description:** 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)

**Measure:** Targeted motor learning of skills involved in breastfeeding

**Time Frame:** 2 weeks

#### Secondary Outcomes

**Description:** Answers to related questions on taVNS-paired breastfeeding parental satisfaction survey

**Measure:** Frequency of breastfeeding assessed by study specific survey

**Time Frame:** 2 months

**Description:** Answers to related questions on taVNS-paired breastfeeding parental satisfaction survey

**Measure:** Parent satisfaction with infant's ability to breastfeed assessed by study specific survey

**Time Frame:** 2 months

**Description:** Answers to related questions on taVNS-paired breastfeeding parental satisfaction survey

**Measure:** Level of connectedness and social-emotional bond felt by mother towards infant assessed by study specific survey

**Time Frame:** 2 months

### Eligibility Module

**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.

**Gender Based:** True

**Gender Description:** The study population will include preterm infants at ≥ 35 weeks post-menstrual age or term infants requiring NICU admission due to medical illness. The study population will also include the infants' mothers who will participate in daily breastfeeding sessions and complete parental satisfaction surveys.

**Healthy Volunteers:** True

**Minimum Age:** 35 Weeks

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** burdge@musc.edu

**Name:** Haley Burdge

**Phone:** 8432144089

**Role:** CONTACT

**Contact 2:**

**Email:** jenkd@musc.edu

**Name:** Dorothea Jenkins

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Charleston

**Contacts:**

***Contact 1:***

- **Email:** burdge@musc.edu

- **Name:** Haley Burdge, MD

- **Phone:** 843-214-4089

- **Role:** CONTACT

***Contact 2:***

- **Email:** jenkd@musc.edu

- **Name:** Dorothea Jenkins, MD

- **Role:** CONTACT

**Country:** United States

**Facility:** Medical University of South Carolina Shawn Jenkins Children's Hospital

**State:** South Carolina

**Status:** RECRUITING

**Zip:** 29425

#### Overall Officials

**Official 1:**

**Affiliation:** Medical University of South Carolina

**Name:** Haley Burdge

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007752

- Term: Obstetric Labor, Premature

- ID: D000007744

- Term: Obstetric Labor Complications

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M25869

- Name: Premature Birth

- Relevance: HIGH

- As Found: Premature Birth

- ID: M10772

- Name: Obstetric Labor, Premature

- Relevance: LOW

- As Found: Unknown

- ID: M10764

- Name: Obstetric Labor Complications

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000047928

- Term: Premature Birth

### Misc Info Module

- Version Holder: 2024-05-31
