NeoBellyBand abdominal support for premature infants on CPAP
Official title: Baby ABS (Abdominal Binder Study) : Impact of Abdominal Binder Use on Abdominal Wall Development in Premature Infants Requiring CPAP Support
Run by University of Minnesota · NCT07049900 · Data updated 2026-11-12
We will try the FDA-approved DandleLion NeoBellyBand on premature infants needing CPAP to see if it thickens their rectus abdominis muscle and helps them reach full oral feedings sooner.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 22 Weeks to 31 Weeks |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Status | Recruiting |
| Started | January 22, 2025 |
| Main results expected | April 30, 2027 |
| Study ends | April 30, 2027 |
| Registry record updated | September 11, 2026 |
| Trial ID | NCT07049900 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Premature viable neonates born at 26–31 weeks gestational age who are expected to need noninvasive CPAP (bCPAP, CPAP, or NAVA CPAP) for at least two weeks are ideal candidates.
✕Probably not a fit
Infants born outside the 26–31 week window, those with umbilical lines, abdominal or neuromuscular anomalies, compromised abdominal skin, prior abdominal surgery, non-viability, or other conditions that would interfere with data collection are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional, single-center study applies the FDA-approved DandleLion NeoBellyBand to premature neonates receiving noninvasive continuous positive pressure ventilation. Rectus abdominis muscle thickness will be measured and feeding milestones tracked while infants remain on bCPAP, CPAP, or NAVA CPAP. The primary outcome is whether the band increases muscle thickness and leads to earlier attainment of full oral feeding by corrected gestational age. The trial enrolls viable neonates born at 26–31 weeks who are expected to require CPAP for at least two weeks.
Why it matters
Potential benefit: If successful, the device could help premature infants build abdominal muscle and reach full oral feedings earlier, potentially shortening NICU stays.
How similar studies have gone: The NeoBellyBand is FDA-approved for neonatal abdominal support, but published evidence specifically showing increased rectus abdominis thickness or faster transition to full oral feedings is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Premature viable neonates with corrected gestational age of 22-31 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
Where it's running
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University of Minnesota
Minneapolis, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Sarah Ramel, MD — University of Minnesota
- Study coordinator: Andrea Charara, MD
- Email: chara061@umn.edu
- Phone: (612) 626-0644
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.