Clinical trial NCT04849507: BabyStrong Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Paired Bottle Feeding to Improve Oral Feeding
Official title: BabyStrong taVNS-Paired Bottle Feeding to Improve Oral Feeding
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Infant Feeding Problems, taVNS
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-04-19
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: If progress in daily oral feeding volumes is \<4ml/kg/d (based on response rate in pilot trial) after 10 days with either treatment A or B, we will offer cross-over to the alternate treatment.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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
* safe to attempt oral feeds every feed without volume limitations by occupational or speech therapists, and
* clinical team has determined will likely need a G-tube.

Exclusion Criteria:

* cardiomyopathy
* unstable bradycardia
* significant respiratory support
* infants of poorly controlled diabetic mothers, defined by obstetrical care providers, HgbA1C\>5.6% or ketonuria.

Primary outcomes:
measure: bradycardia
timeFrame: 30 minutes during taVNS paired-feed
measure: discomfort scores
timeFrame: 30 minutes during taVNS paired-feed
measure: increase in oral feeding volumes
timeFrame: 20 days
Secondary outcomes:
measure: white matter tract neuroplasticity
timeFrame: 10 days
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: