Baby ABS (Abdominal Binder Study)

NCT07049900 | Recruiting FDA Device

• 1 other identifier: PEDS-2025-33787
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Premature; Premature Lungs; Ventilator Lung; Newborn; Rectus Abdominis

Keywords

bCPAP; CPAP; NAVA CPAP

Outcome Measures

Primary Outcomes (1)

• Change in thickness of the rectus abdominis muscle

  Thickness measured by ultrasound

  8 weeks

Study Arms (2)

NeoBelllyBand

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.

Device: NeoBelly Band

Standard NICU Care

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.

Interventions

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.

NeoBelllyBand

Eligibility Criteria

• Age: 26 Weeks - 31 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Premature Birth; Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

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

Study Officials

• Sarah Ramel, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Charara, MD

CONTACT

(612) 626-0644; chara061@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: September 22, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)