Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06417385
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-04-19
Brief Title:
taVNS-Paired Breastfeeding to Improve Breastfeeding at Discharge
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Transcutaneous Auricular Vagus Nerve Stimulation taVNS-Paired Breastfeeding to Improve Breastfeeding at Discharge
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 breastfeedings 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 infants 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None