Baby ABS (Abdominal Binder Study)

NCT ID: NCT07049900

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-22
• Study Completion Date: 2027-02-28

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

NeoBelllyBand

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 Type: ACTIVE_COMPARATOR

NeoBelly Band

Intervention Type: 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.

Standard NICU Care

Infants in this group will receive standard neonatal intensive unit care as defined by the University of Minnesota Masonic Children's Hospital NICU protocol.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

NeoBelly Band

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 26 Weeks
• Maximum Eligible Age: 31 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Ramel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Andrea Charara, MD

Role: CONTACT

chara061@umn.edu

(612) 626-0644

Facility Contacts

Andrea Charara, MD

Role: primary

chara061@umn.edu

612-626-0644

Other Identifiers

PEDS-2025-33787

Identifier Type: -

Identifier Source: org_study_id