MedPath

Baby ABS (Abdominal Binder Study)

Not Applicable
Not yet recruiting
Conditions
Ventilator Lung; Newborn
Rectus Abdominis
Premature
Premature 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
NameTimeMethod
Change in thickness of the rectus abdominis muscle8 weeks

Thickness measured by ultrasound

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Minnesota

🇺🇸

Minneapolis, Minnesota, United States

University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Andrea Charara, MD
Contact
612-626-0644
chara061@umn.edu
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