Baby ABS (Abdominal Binder Study)
Not Applicable
Not yet recruiting
- 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
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie rectus abdominis muscle development in premature infants with ventilator lung disease?
How does the DandleLion NeoBellyBand compare to standard CPAP support in enhancing abdominal wall development in preterm neonates?
Are there specific biomarkers that predict premature infants' response to abdominal binder therapy during CPAP treatment?
What are the potential adverse events associated with abdominal binder use in CPAP-supported preterm infants and how are they managed?
What combination therapies or alternative devices are being explored alongside abdominal binders for improving respiratory and muscular outcomes in premature infants?
Trial Locations
- Locations (1)
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota🇺🇸Minneapolis, Minnesota, United StatesAndrea Charara, MDContact612-626-0644chara061@umn.edu