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Baby ABS (Abdominal Binder Study) for Premature Babies

This study, called Baby ABS, is looking at whether using the DandleLion NeoBellyBand can help premature babies who need breathing support. The NeoBellyBand is an FDA-listed medical device. Researchers want to see if using this band increases the thickness of a muscle in the baby's belly (rectus abdominis muscle). The goal is to help these babies start eating by mouth sooner. The study is for premature babies born between 26 and 31 weeks gestational age who are expected to need breathing support (CPAP) for at least two weeks. The study plans to enroll 40 babies, but its current status is unclear.

Study design
This interventional study plans to enroll 40 premature babies. The phase of the study is not specified.
What's involved
The study will measure the thickness of the rectus abdominis muscle at 8 weeks. Babies will use the NeoBellyBand while receiving CPAP support.
Compensation
Not stated in the trial record.
Follow-up
The primary measurement for this study is taken at 8 weeks.

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NCT07049900

Baby ABS (Abdominal Binder Study)

Recruiting
NAAges 26–31InterventionalSupportive care
University of Minnesota
~40 participants
Updated 2025-09-26 on ClinicalTrials.gov
What's tested:NeoBelly Band

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in thickness of the rectus abdominis muscle
Measured over 8 weeks

Conditions

Premature
Premature Lungs
Ventilator Lung; Newborn
Rectus Abdominis

Explore related trials

Preterm Birth

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Sarah Ramel, MD · PRINCIPAL_INVESTIGATOR · University of Minnesota

Who to contact

Andrea Charara, MD
[email protected]
(612) 626-0644
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in thickness of the rectus abdominis muscle8 weeks

    Thickness measured by ultrasound