Baby ABS (Abdominal Binder Study) : Impact of Abdominal Binder Use on Abdominal Wall Development in Premature Infants Requiring CPAP Support
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 7 months
Healthy Volunteers: f
View:
• 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.
Locations
United States
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Contact Information
Primary
Andrea Charara, MD
chara061@umn.edu
(612) 626-0644
Time Frame
Start Date: 2025-09-22
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 40
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Minnesota