Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07049900

Baby ABS (Abdominal Binder Study)

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Premature Bronchopulmonary Dysplasia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Infant, Premature, Diseases Lung Diseases Lung Injury Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Premature Lungs Rectus Abdominis Respiratory Tract Diseases Urogenital Diseases Ventilator Lung; Newborn Ventilator-Induced Lung Injury

Age range

26 week–31 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Andrea Charara, MD

CONTACT

[email protected]

612-626-0644

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NeoBelly Band

Device

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.

Primary outcomes

  1. Change in thickness of the rectus abdominis muscle

    Time frame: 8 weeks

    Thickness measured by ultrasound

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Charara, MD

CONTACT

[email protected]

(612) 626-0644

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Baby ABS (Abdominal Binder Study) : Impact of Abdominal Binder Use on Abdominal Wall Development in Premature Infants Requiring CPAP Support

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 3, 2025
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.