Abdominal Binder Study on Abdominal Wall Development in Premature Infants on CPAP
This study uses an abdominal binder in premature infants on CPAP to observe if it aids in the development of the abdominal wall, measured by changes in the thickness of the rectus abdominis muscle.
NeoBelly Band
Urogenital Diseases+11
+ Bronchopulmonary Dysplasia
+ Female Urogenital Diseases and Pregnancy Complications
Supportive Care Study
Summary
Study start date: September 22, 2025
Actual date on which the first participant was enrolled.This study explores whether using a specific type of abdominal band, called the DandleLion NeoBellyBand, can help premature babies who need breathing support. The focus is on babies who require continuous positive pressure ventilation (CPAP), a common method to assist their breathing. The goal is to see if this band can make a muscle in their abdomen, the rectus abdominis, thicker. A stronger abdominal muscle might help these infants reach full oral feedings sooner, which is an important milestone for their growth and development. Participants in the study will wear the NeoBellyBand, which is an FDA-approved device, while they are receiving CPAP support. Researchers will measure the thickness of the rectus abdominis muscle to see if there is any improvement. The study aims to determine if the use of this band can positively impact the muscle development of these infants, potentially leading to quicker progress in their ability to feed orally. This could help improve outcomes for premature babies by enhancing their overall development and health.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location