BabyStrong I: BabyStrong Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Paired Bottle Feeding to Improve Oral Feeding
Study Details
Study Description
Brief Summary
Feeding is critical for pre-term infants and term infants with hypoxic ischemic brain injury, in order to be discharged home with their families and avoid a gastrostomy tube (G-tube) placement. The proposed study will employ a novel system that stimulates the vagus nerve through the skin in front part of the ear, the BabyStrong feeding system, to delivered transcutaneous auricular vagus nerve stimulation (taVNS) paired with oral feedings daily for 10 days. In an earlier study at Medical University of South Carolina (MUSC), this type of vagus nerve stimulation resulted in more than half of infants who were slated to receive G-tubes, taking full oral feeds by mouth and avoiding a G-tube. In this study some babies will receive the therapy for 10 days and others will get no stimulation. If no progress is made in feeding volumes by day 10, the infants will be switched to the other treatment for 7 days. Parents, study personnel, and care providers will be blinded to taVNS assignment. The electronic stimulation device is Federal Drug Administration (FDA)-cleared for investigational use, and the BabyStrong has been designated a Breakthrough Medical Device by the FDA. This study will be conducted in MUSC's Neonatal Intensive Care Unit.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
In this Phase I study, we will conduct a small-scale safety and efficacy study of the BabyStrong portable taVNS feeding system. We will test the BabyStrong feeding system using active (n=10) and sham (n=10) taVNS in infants with twice daily (A or B treatment) for 10 days, with cross over to B/A treatment if there is no progress with feeds within 10 days of taVNS treatment. Subsequent A /B treatment will be continued for another 7 days for any treatment effect, prior to arranging for G-tube placement if infant continues to make no progress. If the infant attains full oral feeds and gains weight, they may be discharged at any time during the treatment protocol. The treatment assignment will be blinded to care providers, study personnel and parents. We will compare daily oral feeding volumes over 10 days prior and the 10 days of treatment, and diffusion magnetic resonance imaging (MRI) changes before and after 10 days of taVNS treatment, and after another 7days if the cross-over design is employed. Safety measures will be bradycardia and discomfort, as in our prior taVNS feeding pilot trial, "taVNs paired with bottle feeding in infants failing oral feeds" National Clinical Trials #04643808.
Criteria for success of BabyStrong feeding system: No sustained increase in discomfort scores; No bradycardia; Improvement in daily feeding volumes compared with pre-taVNS, and/or attainment of full oral feeds in 50% of infants; improvement in white matter microstructure by diffusion MRI before and after active treatment.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: active taVNS We will deliver taVNS via the BabyStrong system, with pulses paired with oral feeding, off with rest during 2 feeds a day. Current will be delivered at 0.1milliAmpere (mA) < perceptual threshold (PT), 500microseconds, 25 Hertz (Hz).The ear electrode will be positioned on left tragus for active taVNS. |
Device: transcutaneous auricular vagus nerve stimulation
Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.
Other Names:
|
| Sham Comparator: sham taVNS The ear electrode positioned on left tragus as for active taVNS. We will test the PT with active stimulation, and then program a sham setting on the BabyStrong unit to deliver no current after the PT is determined. |
Device: transcutaneous auricular vagus nerve stimulation
Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- bradycardia [30 minutes during taVNS paired-feed]
safety : episodes of Heart rate < 80beats per minute for 10 seconds
- discomfort scores [30 minutes during taVNS paired-feed]
Neonatal and Infant Pain scale (NIPS) >3 point increase
- increase in oral feeding volumes [20 days]
slopes of daily po volumes over the first 10 days of treatment; compare between sham and active taVNS
Secondary Outcome Measures
- white matter tract neuroplasticity [10 days]
change in fractional anisotropy by diffusion imaging before and after active vs sham treatment
Eligibility Criteria
Criteria
Inclusion Criteria:
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Infants born at any gestational age (GA), failing oral feeds after trying to learn feeding for 2 weeks if term, and 4 weeks if preterm
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safe to attempt oral feeds every feed without volume limitations by occupational or speech therapists, and
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clinical team has determined will likely need a G-tube.
Exclusion Criteria:
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cardiomyopathy
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unstable bradycardia
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significant respiratory support
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infants of poorly controlled diabetic mothers, defined by obstetrical care providers, HgbA1C>5.6% or ketonuria.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
Sponsors and Collaborators
- Medical University of South Carolina
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 108881
- 1R41HD104409