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Abdominal Binder Study on Abdominal Wall Development in Premature Infants on CPAP

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Study AimThis study uses an abdominal binder in premature infants on CPAP to observe if it aids in the development of the abdominal wall, measured by changes in the thickness of the rectus abdominis muscle.
What is being tested

NeoBelly Band

Device
Who is being recruted

Premature
+1

+ Premature Lungs
+ Ventilator Lung; Newborn
+10 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Supportive Care Study

Interventional
Study Start: September 2025

See protocol details

Summary

Principal SponsorUniversity of Minnesota
Study ContactAndrea Charara, MD
Last updated: September 26, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: September 22, 2025Actual date on which the first participant was enrolled.

This study explores whether using a specific type of abdominal band, called the DandleLion NeoBellyBand, can help premature babies who need breathing support. The focus is on babies who require continuous positive pressure ventilation (CPAP), a common method to assist their breathing. The goal is to see if this band can make a muscle in their abdomen, the rectus abdominis, thicker. A stronger abdominal muscle might help these infants reach full oral feedings sooner, which is an important milestone for their growth and development. Participants in the study will wear the NeoBellyBand, which is an FDA-approved device, while they are receiving CPAP support. Researchers will measure the thickness of the rectus abdominis muscle to see if there is any improvement. The study aims to determine if the use of this band can positively impact the muscle development of these infants, potentially leading to quicker progress in their ability to feed orally. This could help improve outcomes for premature babies by enhancing their overall development and health.

Official TitleBaby ABS (Abdominal Binder Study) : Impact of Abdominal Binder Use on Abdominal Wall Development in Premature Infants Requiring CPAP Support 
Principal SponsorUniversity of Minnesota
Study ContactAndrea Charara, MD
Last updated: September 26, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
40 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Premature
Premature Lungs
Ventilator Lung; Newborn
Rectus Abdominis
Criteria
2 inclusion criteria required to participate
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
8 exclusion criteria prevent from participating
Outside of gestational age at birth
Umbilical lines
Genetic condition or neuromuscular anomaly
Known abdominal anomaly

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Active Comparator
Infants in this group will continue to have standard NICU care, with the addition of wearing the NeoBellyBand device while they remain on CPAP.
Group II
No Intervention
Infants in this group will receive standard neonatal intensive unit care as defined by the University of Minnesota Masonic Children's Hospital NICU protocol.
Study Objectives
Primary Objectives

Thickness measured by ultrasound

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
University of MinnesotaMinneapolis, United StatesSee the location
Recruiting
One Study Center