NCT07049900

Baby ABS (Abdominal Binder Study)

Baby ABS (Abdominal Binder Study) : Impact of Abdominal Binder Use on Abdominal Wall Development in Premature Infants Requiring CPAP Support

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 26 Weeks – 31 Weeks
• Healthy volunteers: Not accepted

Summary

The primary outcome of this study is to determine if the use of the FDA-approved DandleLion NeoBellyBand increases the thickness of the rectus abdominis muscle in premature babies receiving continuous positive pressure ventilation, leading to infants reaching full oral feedings at an earlier corrected gestational age.

Conditions

• Premature
• Premature Lungs
• Ventilator Lung; Newborn
• Rectus Abdominis

Interventions

Type	Name	Description
DEVICE	NeoBelly Band	The DandleLion NeoBellyBand (NBB) is an FDA listed Class 1 medical device that is 510k exempt and is categorized under therapeutic medical binders. This device is indicated to be used while the infant is receiving CPAP support in order to reduce CBS. The NBB is made of a medical-grade blend of fabric and foam that is latex and neoprene-free and is reported as safe to use on premature infant skin. There are two sizes available and the outer fabric is attached with adjustable Velcro. It is a single baby use and may be hand washed and reused. This device is currently in use in multiple NICUs around the country, and as it has already been FDA-approved for the purpose of our investigation.

Timeline

• Start date: 2025-09-22
• Primary completion: 2026-09-30
• Completion: 2027-02-28
• First posted: 2025-07-03
• Last updated: 2025-09-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study