Baby ABS (Abdominal Binder Study)

NARecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

September 22, 2025

Primary Completion Date

September 30, 2026

Study Completion Date

February 28, 2027

Conditions
PrematurePremature LungsVentilator Lung; NewbornRectus Abdominis
Interventions
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.

Trial Locations (1)

55455

RECRUITING

University of Minnesota, Minneapolis

All Listed Sponsors
lead

University of Minnesota

OTHER

NCT07049900 - Baby ABS (Abdominal Binder Study) | Biotech Hunter | Biotech Hunter