taVNS-Paired Breastfeeding to Improve Breastfeeding at Discharge
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: taVNS soterix device.
- Who it may be relevant to
- Registry conditions: Premature Birth, Breastfeeding, Exclusive, Feeding; Difficult, Newborn. Basic parameters: from 35 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)-Paired Breastfeeding to Improve Breastfeeding at Discharge
Overview
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.
Interventions
- 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.
Primary outcome measures
- Adequate volume transfer during breastfeeding [Time frame: 2 weeks]
- Infant's ability to sustain breastfeeding for a length of time [Time frame: 2 weeks]
- Targeted motor learning of skills involved in breastfeeding [Time frame: 2 weeks]
- Targeted motor learning of skills involved in breastfeeding [Time frame: 2 weeks]
Secondary outcome measures (3)
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Medical University of South Carolina Shawn Jenkins Children's Hospital — Charleston
Identifiers
NCT: NCT06417385 · Pro00131771