Baby ABS (Abdominal Binder Study)
Launched by UNIVERSITY OF MINNESOTA · Jun 25, 2025
Trial Information
Current as of July 27, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial, called Baby ABS (Abdominal Binder Study), is looking at whether using a special belly band called the DandleLion NeoBellyBand can help premature babies who need breathing support. The study wants to see if this band can make a key tummy muscle (called the rectus abdominis) thicker, which might help these babies start feeding by mouth sooner and grow stronger more quickly.
The study is for premature babies who are about 26 to 31 weeks in corrected gestational age and who need continuous breathing support through gentle pressure, like CPAP, for at least two weeks. Babies with certain health issues, like genetic conditions or abdominal problems, won’t be able to join. If eligible, families can expect their baby to wear the belly band while receiving breathing support, and the researchers will check if it helps the baby’s tummy muscle grow and if they can feed by mouth earlier. This study hasn’t started enrolling participants yet, but it aims to find a simple way to support the health and feeding progress of these fragile newborns.
Gender
ALL
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
About University Of Minnesota
The University of Minnesota is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a focus on interdisciplinary collaboration, the university leverages its extensive resources and expertise to conduct cutting-edge studies aimed at improving patient outcomes and addressing critical health challenges. Its robust clinical trial program emphasizes ethical standards, patient safety, and scientific rigor, contributing to the development of novel therapies and interventions that enhance medical practice and public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Minneapolis, Minnesota, United States
Patients applied
Trial Officials
Sarah Ramel, MD
Principal Investigator
University of Minnesota
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported