Study of the NeoBellyBand Device to Support Abdominal Muscle Growth in Premature Infants on CPAP Support

What this Trial Is About

Researchers are evaluating the impact of the FDA-approved DandleLion NeoBellyBand on the abdominal muscle development of premature infants who require continuous positive pressure ventilation CPAP. The study aims to see if using this abdominal binder increases the thickness of the rectus abdominis muscle and helps infants reach full oral feedings sooner at their corrected gestational age. This study is sponsored by the University of Minnesota and focuses on premature newborns between 26 and 31 weeks of corrected gestational age. Participants are randomly assigned to one of two groups. One group will receive standard neonatal intensive care while wearing the NeoBellyBand device during CPAP support. The other group will receive standard neonatal intensive care without the device. The NeoBellyBand is a medical device made from safe, medical-grade fabric and foam, designed for single baby use and adjustable with Velcro. The device is used while the infant remains on CPAP support, which may include bCPAP, CPAP, or NAVA CPAP. During the 8-week study period, infants will be monitored to measure changes in the thickness of their rectus abdominis muscle. Researchers will track how quickly infants reach full oral feedings at their corrected age, along with observing other health indicators. Data collection will focus on the muscle development outcome, and infants will receive care according to standard NICU protocols. The study will end in February 2027, with ongoing assessments to confirm safety and effectiveness of the device in supporting abdominal wall development.

Baby ABS (Abdominal Binder Study)