Baby ABS (Abdominal Binder Study)

University of Minnesota (UMN)

Status: Enrolling

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

Treatments: Device: NeoBelly Band

Study type: Interventional

Funder types: Other

Identifiers

NCT07049900

PEDS-2025-33787

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 26 to 31 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

NeoBelllyBand

Active Comparator group

Description:

Infants in this group will continue to have standard NICU care, with the addition of wearing the NeoBellyBand device while they remain on CPAP.

Treatment:

Device: NeoBelly Band

Standard NICU Care

No Intervention group

Description:

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