BridgeMD
New treatment option for Feeding Delays
Official title BabySTrong II taVNS Feeding Trial
ClinicalTrials.gov ID: NCT07049952
What this study is testing
What is NAC and taVNS?
NAC and taVNS is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for feeding delays.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 39 to 54
You may be able to join if
- infants \>39 weeks PMA making minimal progress in oral feeds
- trying to learn feeding for at least 2wks if beginning feeds at term (\>37wks PMA), and 4wks if beginning feeds \<36wks PMA,
- may po every feed without volume limitations by therapists
You likely can't join if
- cardiomyopathy
- unstable apnea/bradycardia
- significant respiratory support (CPAP/ Vapotherm)
- unrepaired major congenital anomalies that affect safe po feeding or impose volume restrictions
- congenital syndromes unlikely to orally feed
The study team makes the final eligibility decision.
Where it's taking place
- Charleston, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 39 weeks to 54 weeks. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.