Actively Recruiting
Baby ABS (Abdominal Binder Study)
Led by University of Minnesota · Updated on 2025-09-26
40
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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
Trial Site Locations
Total: 1 location
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
Research Team
A
Andrea Charara, MD
CONTACT
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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