Baby ABS (Abdominal Binder Study)

Recruiting now · Not applicable

Conditions studied: Premature, Premature Lungs, Ventilator Lung; Newborn, Rectus Abdominis

In brief

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.

Key facts

Study ID

NCT07049900

Run by

University of Minnesota

People needed

40

Starts

2025-09-22

Expected to finish

2027-02-28

Last updated by the study team

2025-09-26

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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