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Recruiting NCT07049900

Baby ABS (Abdominal Binder Study)

No phase Interventional Premature Premature Lungs Ventilator Lung; Newborn Rectus Abdominis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NeoBelly Band.
Who it may be relevant to
Registry conditions: Premature, Premature Lungs, Ventilator Lung; Newborn, Rectus Abdominis. Basic parameters: 26 Weeks — 31 Weeks · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Baby ABS (Abdominal Binder Study) : Impact of Abdominal Binder Use on Abdominal Wall Development in Premature Infants Requiring CPAP Support

Overview

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.

Interventions

  • 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 singl

Primary outcome measures

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Minnesota — Minneapolis

Identifiers

NCT: NCT07049900 · PEDS-2025-33787

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗