An interventional study of NeoBelly Band in Premature, Premature Lungs and Ventilator Lung; Newborn, sponsored by University of Minnesota. Recruiting at 1 site in United States. Open to participants aged 22 Weeks to 31 Weeks. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by University of Minnesota · Not applicable, Interventional, and Supportive care
Among 11 studies in Premature Birth by University of Minnesota — 3 open to participants now, 4 under way, none of them phase 3. Premature Birth · University of Minnesota.
Among the 11 studies in Premature Birth by University of Minnesota, this one is the only one that started in 2025, is one of 4 with no phase, and was the 10th registered.
2,553 studies on the registry are indexed under Premature Birth; 502 are open to participants now.
Browse Premature Birth studies →3 of the 11 studies in Premature Birth by University of Minnesota are open now, in 1 country. Recruiting first, the newest first:
University of Minnesota · Sites in United States
Ages 28 wk–34 wk
University of Minnesota · Sites in United States
Ages 0–6
By country, each count listing its studies:
Of the 315 Premature Birth studies recruiting now, 88 (28%) set no upper age limit and 223 (71%) stop at 75 or younger; 241 take children under 18; 105 take healthy volunteers.
This study: 22 Weeks to 31 Weeks · all sexes · no healthy volunteers.
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11 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2025.
This study's planned enrollment of 40 is below the median of 84 across 1,669 interventional studies indexed under Premature Birth.
Median enrollment 40 across the 5 interventional studies, 74 across the 6 observational. Of the 7 that completed or were terminated, 1 (14%) have results posted.
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University of Minnesota is the lead sponsor of 1,216 studies on the registry; 196 are open to participants now.
Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.
2 of the studies in Premature Birth by University of Minnesota that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07049900University of MinnesotaBaby ABS (Abdominal Binder Study) | 2027-04-30 |
| NCT05537454University of MinnesotaMaternal Stress, Milk Composition, and Preterm Neurodevelopment | 2027-07-31 |
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Among the 11 studies in Premature Birth by University of Minnesota, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Infants in this group will receive standard neonatal intensive unit care as defined by the University of Minnesota Masonic Children's Hospital NICU protocol.
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.
Change in thickness of the rectus abdominis muscle
Thickness measured by ultrasound
Time frame: 8 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for Apr 2027, 27 months after the start.
Of 744 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 27 months is above that.
Counting every sponsor, half of 762 studies reached it within 24 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
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