Recruiting

DandleLion NeoBellyBand

Sponsor:

University of Minnesota

Code:

NCT07049900

Conditions

Premature

Premature Lungs

Ventilator Lung; Newborn

Rectus Abdominis

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

NeoBelly Band

Study Details

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 ID

NCT07049900

Start date

Sep 22, 2025

Status verified date

Sep, 2025

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

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.

Primary outcome measure

  • Change in thickness of the rectus abdominis muscle [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Andrea Charara, MD

(612) 626-0644chara061@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Andrea Charara, MD

612-626-0644chara061@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Sep 26, 2025

Last verified

Sep, 2025

Keywords

  • bCPAP
  • CPAP
  • NAVA CPAP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2025-09-26.