Clinical trial NCT06417385: taVNS-Paired Breastfeeding to Improve Breastfeeding at Discharge
Official title: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)-Paired Breastfeeding to Improve Breastfeeding at Discharge
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature Birth
Breastfeeding, Exclusive
Feeding; Difficult, Newborn
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 10
Sex: ALL
Minimum age (years): 35
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Adequate volume transfer during breastfeeding
timeFrame: 2 weeks
measure: Infant's ability to sustain breastfeeding for a length of time
timeFrame: 2 weeks
measure: Targeted motor learning of skills involved in breastfeeding
timeFrame: 2 weeks
measure: Targeted motor learning of skills involved in breastfeeding
timeFrame: 2 weeks
Secondary outcomes:
measure: Frequency of breastfeeding assessed by study specific survey
timeFrame: 2 months
measure: Parent satisfaction with infant's ability to breastfeed assessed by study specific survey
timeFrame: 2 months
measure: Level of connectedness and social-emotional bond felt by mother towards infant assessed by study specific survey
timeFrame: 2 months
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina Shawn Jenkins Children's Hospital
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Haley Burdge
role: PRINCIPAL_INVESTIGATOR
References: