NCT Number: NCT07049952
The long-term goal of this project is to develop a therapy to assist pre-term and term infants with brain injury overcome difficulties in learning to feed so that infants may be discharged home with their families and avoid the burdens of of a gastrostomy tube (G-tube) or prolonged home nasogastric feeding. Few other therapies exist for infants who are not making progress with feeding volumes at term age.
To tackle this problem, we took the novel approach of pairing non-invasive nerve stimulation of the vagus nerve at the ear (taVNS) stimulation with the motor skills of feeding. In our pilot studies, 54% (19 out of 35) infants with feeding delays whose families were in discussions for G-tube placement, reached full oral feeds within 2 weeks, and infants who did not reach full feeds still improved their daily oral feeding volumes. Infants who got to full feeds showed stronger and more complex brain circuits associated with feeding motor skills.
With this trial we will test the BabySTrong taVNS feeding system in a multicenter, randomized, controlled, blinded trial to show how well this feeding system works in improving the daily feeding volumes, the days to full oral feeds, and/or the number of infants who avoid G-tube/ home NG placement, and increasing connections in brain circuits. If this groundbreaking new approach to infant feeding is successful, we may decrease how long infants are in the hospital, costs with Gtubes and home NG feeds, and family and care provider burdens. The findings from this proposal will be used in our FDA application for the BabySTrong feeding system.
Interested in participating?
Request Info39 week–54 week
All sexes
Interventional
Phase 2 / Phase 3
Charleston, South Carolina, 29425, United States
Location status: Recruiting
Dorothea D Jenkins, MD
CONTACT
Heather McGhee, PhD SLP
SUB_INVESTIGATOR
Hunter Moss, PhD
SUB_INVESTIGATOR
Sandra Garner, PharmD
SUB_INVESTIGATOR
In this STTR, we will test the safety and efficacy of the BabyStrong taVNS feeding system in infants with feeding delays in a randomized, controlled, triple blinded, multicenter trial. With this safety and efficacy data, we intend to apply for FDA approval and commercially develop the BabyStrong feeding device.
Aim 1) Determine if twice daily active taVNS-paired feeding treatment increases the number of infants reaching full oral feeds or daily oral feeding volumes, or decreases the time to attain full oral feeds compared with infants receiving sham stimulation in a randomized, controlled, triple-blinded trial. We will randomize based on non-IDM or IDM status to 4 groups: IDMs will be randomized 1:1 to Active taVNS-paired feeds (Group T), or sham taVNS paired with feeds (Non-IDM Control); For IDM infants we will randomize 1:1 to N-acetylcysteine (NAC) and active taVNS-paired feeds (Group NT), or placebo and sham taVNS (IDM Control). Blinded randomized treatments will continue for 14 days, then all infants may progress to open label treatment, based on IDM status, for another 10days or less if full oral feeds or a decision to place a G-tube is reached. This study design will allow us to randomize to appropriate treatment based on IDM status. We will combine groups for analyses (Any active taVNS versus Control groups (IDM and Non-IDM combined), while controlling for IDM status. We hypothesize that any taVNS treatment (T + NT) will be effective at improving oral feeds over control (C).
We will also perform within stratified group analyses of active treatment versus control. We will use the non-IDM group results to support an FDA application.
Aim 2) Determine if active taVNS-paired feeding induces neuroplasticity compared with sham treated infants. We will measure diffusion kurtosis and tensor metrics in DKI scans at baseline and at the end of the 14d randomized treatment. We expect increased complexity (mean kurtosis) in corticospinal tracts in active vs sham groups.
Aim 3) Use safety and efficacy data to finalize an application for FDA approval of the BabyStrong, as a system with demonstrated potential to accelerate oromotor learning and decrease the need for Gubes and home NG feeds in infants.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Active or inactive non-invasive vagus nerve stimulation of the auricular branch of the vagus nerve paired with 2 oral feedings/day for 14d
NAC 100 mg/kg diluted 1:3 with sterile water (or equal volume sterile water), q6h NG 1h before a feed for 4d prior to delivering active or sham taVNS paired with 2 feeds/day for 14d with NAC (or sterile water).
inactive transcutaneous auricular vagus nerve stimulation with 2 feeds/day x 14 days
Sterile water per NG tube every 6h for 4 days, then continuing with 14days of inactive taVNS paired with oral feeding
Time frame: 24 days
number of participants achieving full oral feeds receiving ANY active taVNS (groups T+NT), vs Control (IDM combined with Non IDM control groups), based on the randomized assignment.
Time frame: 7days / 10days
mean daily rate of increase in oral feeding volumes in any active taVNS group (T+NT) vs Control (IDM and Non-IDM combined), based on randomized treatment assignment.
Time frame: 24 days
days to full oral feeds in any taVNS (groups T+NT) vs Control
Time frame: 14 days
increased mean kurtosis (complexity ) or FA (integrity) in corticospinal tracts in any active taVNS (Groups T+ NT) vs Control groups
Contact information is provided by the study sponsor or research team.
Dorothea D Jenkins, MD
CONTACT
Gary Connor, RN
CONTACT
Medical University of South Carolina
Other
BabyStrong II (Stimulating the Tragus for Neural Growth): A Randomized Controlled Trial of taVNS-Paired Bottle Feeding to Improve Oral Feeding
Acronym: BabySTrong II
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
