Early Phase 1
N=35
taVNS Paired With Bottle Feeding in Infants Failing Oral Feeds
Poor Feeding · Infant Development · Vagus Nerve Stimulation
Bottom Line
View on ClinicalTrials.gov: NCT04643808 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Number of Infants Who Took All Feeds by Mouth (Responders) — 8; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- transcutaneous auricular vagus nerve stimulation (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Infants Who Took All Feeds by Mouth (Responders) |
8; 11 | — |
| PRIMARY ml/kg/d Increase Over 7d During taVNS |
3.9; 6.0 | — |
| PRIMARY Neuroplasticity as Measured by the Change in White Matter Tract Integrity Via Fractional Anisotropy |
0.07; 0.02 | — |
| SECONDARY Number of Episodes of Bradycardia |
1; 0 | — |
| SECONDARY Number of Treatment Sessions With Sustained Increase in 'Neonatal and Infant Pain Scale' (NIPS) Scores During taVNS |
3; 0 | — |
Summary
Oromotor dysfunction and poor feeding is common after premature birth and hypoxic ischemic encephalopathy (HIE). Pairing vagus nerve stimulation (VNS) with motor activity accelerates functional improvements after stroke. This study is designed to investigate whether transcutaneous auricular VNS (taVNS) paired with oromotor rehabilitation is tolerable, safe, and facilitates motor learning in infants who have failed oral feeding.
Eligibility Criteria
Inclusion Criteria
- Infants must be clinically stable, on minimal respiratory support (nasal cannula, or room air), are not restricted for attempting every feed by mouth, and are currently failing oral feeding such that the clinical team is broaching gastrostomy tube (G-tube) placement with the parents. The infant will be greater than or equal to 39weeks gestation at enrollment and either
- Premature at birth and attempting oral feeds for at least 3 weeks or
- Infants who are neart-term or term at birth, with significant medical issues that have precluded oral feeding, such as hypoxic ischemic encephalopathy (HIE), and attempting oral feeds for at least 2 weeks.
Exclusion Criteria
- Unstable infants or those requiring positive pressure respiratory support.
- Infants <38weeks gestation at enrollment.
- Major unrepaired congenital anomalies or anomalies that limit feeding volumes
- Cardiomyopathy
- Repeated episodes of autonomic instability (apnea or bradycardia) which are not self resolving
Data sourced from ClinicalTrials.gov (NCT04643808). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.