Baby ABS (Abdominal Binder Study)

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT07049900
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
26 Weeks - 31 Weeks
Healthy Volunteers
Not accepted

Interventions

  • NeoBelly Band — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Sep 22, 2025
Status verified
Sep 2025
Primary completion
Sep 30, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: NeoBelllyBand
    Infants in this group will continue to have standard NICU care, with the addition of wearing the NeoBellyBand device while they remain on CPAP.
  • No Intervention: Standard NICU Care
    Infants in this group will receive standard neonatal intensive unit care as defined by the University of Minnesota Masonic Children's Hospital NICU protocol.

Primary Outcome Measure

Change in thickness of the rectus abdominis muscle [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455
Andrea Charara, MD
[email protected]
612-626-0644

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