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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

Bronchopulmonary Dysplasia
+11

+ Female Urogenital Diseases and Pregnancy Complications
+ Infant, Newborn, Diseases
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: December 11, 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 
NCT07049900
Principal SponsorUniversity of Minnesota
Study ContactAndrea Charara, MD
Last updated: December 11, 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 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.
Range of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Bronchopulmonary Dysplasia
Female Urogenital Diseases and Pregnancy Complications
Infant, Newborn, Diseases
Infant, Premature, Diseases
Obstetric Labor Complications
Obstetric Labor, Premature
Lung Diseases
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Pregnancy Complications
Respiratory Tract Diseases
Premature Birth
Lung Injury
Ventilator-Induced Lung Injury
Urogenital Diseases
Criteria

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 Plan

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

is 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.

The DandleLion NeoBellyBand (NBB) is an FDA listed Class 1 medical device that is 510k exempt and is categorized under therapeutic medical binders. This device is indicated to be used while the infant is receiving CPAP support in order to reduce CBS. The NBB is made of a medical-grade blend of fabric and foam that is latex and neoprene-free and is reported as safe to use on premature infant skin. There are two sizes available and the outer fabric is attached with adjustable Velcro. It is a single baby use and may be hand washed and reused. This device is currently in use in multiple NICUs around the country, and as it has already been FDA-approved for the purpose of our investigation.
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
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One Study Center