Trials Today

Baby ABS (Abdominal Binder Study)

Purpose

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

Eligibility

Eligible Ages: Between 26 Weeks and 31 Weeks
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Supportive Care
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Active Comparator 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.	Device: 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.
No Intervention 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.

Recruiting Locations

University of Minnesota
Minneapolis, Minnesota 55455

Contact:
Andrea Charara, MD
612-626-0644
chara061@umn.edu

More Details

NCT ID: NCT07049900
Status: Recruiting
Sponsor: University of Minnesota

Study Contact

Andrea Charara, MD
(612) 626-0644
chara061@umn.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.