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Baby ABS (Abdominal Binder Study)

Baby ABS (Abdominal Binder Study)

Recruiting
26-31 years
All
Phase N/A

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Overview

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

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 details
    Premature
    Premature Lungs
    Ventilator Lung; Newborn
    Rectus Abdominis

NCT07049900

University of Minnesota

15 October 2025

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