Baby ABS (Abdominal Binder Study)
- Conditions
- Ventilator Lung; NewbornRectus AbdominisPrematurePremature Lungs
- Registration Number
- NCT07049900
- Lead Sponsor
- University of Minnesota
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in thickness of the rectus abdominis muscle 8 weeks Thickness measured by ultrasound
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (1)
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota🇺🇸Minneapolis, Minnesota, United StatesAndrea Charara, MDContact612-626-0644chara061@umn.edu