Recruiting

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

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Study Aim

This 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

Urogenital Diseases+11

+ Bronchopulmonary Dysplasia

+ Female Urogenital Diseases and Pregnancy Complications

+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: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 22, 2025

Actual 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: January 28, 2026
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 enrolled

Total 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.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesBronchopulmonary DysplasiaFemale Urogenital Diseases and Pregnancy ComplicationsInfant, Newborn, DiseasesInfant, Premature, DiseasesObstetric Labor ComplicationsObstetric Labor, PrematureLung DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPregnancy ComplicationsRespiratory Tract DiseasesPremature BirthLung InjuryVentilator-Induced Lung Injury

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

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.

Study Objectives

Primary Objectives

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 Minnesota

Minneapolis, United StatesOpen University of Minnesota in Google Maps
Recruiting
One Study Center