NeoBelly Band for Premature Birth
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether the NeoBelly Band, a supportive device, can help premature babies strengthen their stomach muscles and reach full oral feedings sooner. It targets babies born between 26 and 31 weeks who require a breathing aid called CPAP for at least two weeks. Babies with abdominal conditions or other serious health issues are not eligible. Participants will either receive standard care in the NICU or have the NeoBelly Band added to their care routine. The goal is to determine if the NeoBelly Band provides additional benefits compared to standard care alone. As an unphased trial, this study offers families a unique opportunity to contribute to innovative research that could improve care for premature infants.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What prior data suggests that the NeoBelly Band is safe for premature babies?
Research has shown that the NeoBelly Band, made from a special fabric and foam blend, is safe for the sensitive skin of premature babies. The FDA has approved this device, indicating it meets specific safety standards. The NeoBelly Band is light and breathable, ensuring comfort for infants.
Although limited data exists on side effects, the available information and FDA approval for use in premature babies provide some confidence in its safety. This trial aims to discover additional benefits of the device, rather than assess its safety, as it is already approved.12345Why are researchers excited about this trial?
Researchers are excited about the NeoBelly Band because it offers a novel approach to supporting premature infants in the NICU. Unlike traditional treatments that solely rely on standard neonatal intensive care, the NeoBelly Band is worn by infants while they are on CPAP (Continuous Positive Airway Pressure). This new device aims to enhance the benefits of CPAP by potentially improving lung function and comfort for the baby. By integrating this wearable technology into existing care protocols, researchers hope to provide a more comprehensive support system for these vulnerable infants.
What evidence suggests that the NeoBelly Band is effective for premature birth?
Research shows that the NeoBelly Band might help premature babies by strengthening their tummy muscles, potentially enabling them to start eating by mouth sooner. In this trial, one group of infants will receive standard NICU care along with the NeoBelly Band while on CPAP. Studies have found that the NeoBelly Band provides belly support, which can benefit babies using breathing support machines like CPAP by reducing bloating. Some early findings suggest that this band could also help prevent feeding interruptions. Although more research is needed, initial results are promising for aiding the growth and development of premature babies.23567
Who Is on the Research Team?
Sarah Ramel, MD
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
This trial is for premature babies with lung problems like Bronchopulmonary Dysplasia who are on ventilators. The study aims to see if wearing a special band can help strengthen their abdominal muscles and improve feeding.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Infants receive standard NICU care with or without the NeoBellyBand device while on CPAP
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- NeoBelly Band
Trial Overview
The NeoBelly Band, an FDA-approved device, is being tested to see if it can increase the thickness of the rectus abdominis muscle in these infants and help them achieve full oral feedings sooner.
How Is the Trial Designed?
2
Treatment groups
Active Control
Infants in this group will continue to have standard NICU care, with the addition of wearing the NeoBellyBand device while they remain on CPAP.
Infants in this group will receive standard neonatal intensive unit care as defined by the University of Minnesota Masonic Children's Hospital NICU protocol.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor
Citations
Abdominal Binders to Minimize Enteral Nutrition ...
The goal of this study is to learn if a foam belly strap, called "NeoBellyBand," can help with belly bloating, pauses in feedings, ...
Neonatal abdominal support to address CPAP belly
An intervention to provide abdominal support to address CPAP belly is presented in these case studies. Keywords: Abdominal binder; CPAP belly; neonatal; ...
Are you concerned about abdominal distension? - Dandle
Ginny McGill discusses her journey with "CPAP Belly," an abdominal distension due to CPAP. She created the NeoBellyBand™ as a form of ...
Effectiveness of different bathing methods on physiological ...
The results of meta-analysis showed that the body temperature and oxygen saturation of preterm infants in the sponge bath group were lower than ...
NeoBelly Band for Premature Birth
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 ...
NeoBellyBand
The NeoBellyBand features: · Medical-grade blend of fabric and foam that has been used safely on premature skin · Soft foam inlay that is lightweight, breathable, ...
Continuous Positive Airway Pressure Belly Syndrome
We present the case of an extreme preterm infant with severe CPAP belly syndrome that required rescue intubation due to a massively distended abdomen.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.