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Baby ABS (Abdominal Binder Study)
Baby ABS (Abdominal Binder Study) : Impact of Abdominal Binder Use on Abdominal Wall Development in Premature Infants Requiring CPAP Support
Who can join
22 Weeks – 31 Weeks · All sexes
Full eligibility 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
About the study
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.
What is being tested
- NeoBelly Band (device)
Sponsor: University of Minnesota · Participants: 40 · Started: Jan 22, 2025
Contact the study team
- Andrea Charara, MD · Phone: (612) 626-0644
Official record on ClinicalTrials.gov — NCT07049900
Locations in the U.S.
| Minnesota | University of Minnesota, Minneapolis |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.