Actively Recruiting
Baby ABS (Abdominal Binder Study) Impact of Abdominal Binder Use on Abdominal Wall Development in Premature Infants Requiring CPAP Support
Led by University of Minnesota · Updated on 2025-09-26
40
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Baby ABS (Abdominal Binder Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Premature viable neonates with corrected gestational age of 26-31 weeks
- Anticipated to require non-invasive continuous positive pressure ventilation including bCPAP, CPAP, and NAVA CPAP for a minimum of 2 weeks either on their first trial of CPAP or after extubation.
You will not qualify if you...
- Outside of gestational age at birth
- Umbilical lines
- Genetic condition or neuromuscular anomaly
- Known abdominal anomaly
- Non-viable neonates and neonates with uncertain viability who are not anticipated to be able to survive with standard NICU care.
- Surgical intervention on the abdominal wall, such as gastroschisis or history of surgical NEC
- Compromised skin integrity of abdominal wall
- Any condition in the opinion of the investigator that would risk the data integrity or collection of the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 2 weeks during CPAP support
Participants receive the NeoBellyBand device while on CPAP support or continue with standard NICU care, to evaluate the impact on abdominal wall development.
Ongoing care during NICU stay with device use as applicable
Duration - 8 weeks
Participants are monitored for changes in abdominal muscle thickness over 8 weeks after treatment initiation.
Assessments approximately at 8 weeks post-treatment start
Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
A
Andrea Charara, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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