Using nerve stimulation to help premature infants breastfeed better
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)-Paired Breastfeeding to Improve Breastfeeding at Discharge
This study is testing if a gentle nerve stimulation can help premature and sick term babies learn to breastfeed better while they're in the NICU.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 35 Weeks and up |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Trial ID | NCT06417385 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance breastfeeding skills in premature or sick term infants by using transcutaneous vagus nerve stimulation (taVNS) to boost motor learning. A total of 10 infants, who are at least 35 weeks gestational age and admitted to the NICU, will receive daily taVNS treatments paired with breastfeeding for up to 14 days. The stimulation will be adjusted to a level that provides a slight tingle without discomfort, coinciding with the infant's latching and sucking during feeds. Data on feeding performance, including weight gain and feeding techniques, will be collected to assess the effectiveness of this intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are infants who are at least 35 weeks post-menstrual age, clinically stable, and struggling with breastfeeding despite lactation consultant support.
Not a fit: Patients who may not benefit include those with significant respiratory support, cardiomyopathy, or contraindications to breastfeeding.
Why it matters
Potential benefit: If successful, this approach could significantly improve breastfeeding outcomes for premature infants, enhancing their nutrition and health.
How similar studies have performed: While the use of taVNS in this context is novel, similar approaches in enhancing motor learning have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Charleston, South Carolina
- Medical University of South Carolina Shawn Jenkins Children's Hospital — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Haley Burdge — Medical University of South Carolina
- Study coordinator: Haley Burdge
- Email: burdge@musc.edu
- Phone: 8432144089
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.