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NCT06417385 · ClinicalTrials.gov registry record · NA
taVNS-Paired Breastfeeding to Improve Breastfeeding at Discharge
A NA study of Premature Birth and Breastfeeding, Exclusive, sponsored by Medical University of South Carolina.
- Recruiting
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT06417385: Recruiting NA study of Premature Birth and Breastfeeding, Exclusive, sponsored by Medical University of South Carolina.
NCT06417385 is a NA study of Premature Birth and Breastfeeding, Exclusive that is actively recruiting participants, run by Medical University of South Carolina. The registered enrollment target is 10 participants, below the 394-participant average among 38 other Premature Birth trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06417385, a NA study of Premature Birth and Breastfeeding, Exclusive, is actively recruiting participants, sponsored by Medical University of South Carolina.
- RECRUITING
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Measured by pre- and post-feed weights (grams)
Conditions Studied
Interventions
- DEVICE taVNS soterix device
Study Locations (1)
South Carolina
- Medical University of South Carolina Shawn Jenkins Children's Hospital - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2024-02-01 |
| Est. Completion | 2027-06-01 |
| Phase | NA |
What NCT06417385 shows while recruiting
NCT06417385 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 394-participant average among 38 other Premature Birth trials with a reported enrollment target (97% lower).
The record links to 3 conditions, with Premature Birth appearing as the primary indexed condition, and to 1 intervention - of which taVNS soterix device is the first listed.
NCT06417385 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT06417385 about?
NCT06417385 is a clinical study titled "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 pa...
What is the current status of trial NCT06417385?
This trial is currently recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2024-02-01. Estimated completion is 2027-06-01.
What conditions does trial NCT06417385 study?
This clinical trial studies the following conditions: Premature Birth, Breastfeeding, Exclusive, Feeding; Difficult, Newborn.
What interventions are being tested in trial NCT06417385?
The interventions under investigation include: taVNS soterix device (DEVICE).
Who is sponsoring clinical trial NCT06417385?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06417385 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06417385's enrollment target sits among peer trials
10 39th of 38 the lowest of 38 other Premature Birth trials
participants (enrollment target), bucketed by value
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