| NCT ID | NCT07049900 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Minnesota |
| Condition | Premature |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-09-22 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-09-22 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Sarah Ramel, MD
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT07049900 clinical trial?
This trial is open to participants of all sexes, aged 26 Weeks or older, up to 31 Weeks, studying Premature. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07049900 currently recruiting?
Yes, NCT07049900 is actively recruiting participants. Contact the research team at chara061@umn.edu for enrollment information.
Where is the NCT07049900 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT07049900 clinical trial?
NCT07049900 is sponsored by University of Minnesota. The principal investigator is Sarah Ramel, MD at University of Minnesota. The trial plans to enroll 40 participants.