Premature, Premature Lungs, Rectus Abdominis, Ventilator Lung; Newborn
Conditions
Keywords
bCPAP, CPAP, NAVA CPAP
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.
Interventions
DEVICENeoBelly Band
The DandleLion NeoBellyBand (NBB) is an FDA listed Class 1 medical device that is 510k exempt and is categorized under therapeutic medical binders. This device is indicated to be used while the infant is receiving CPAP support in order to reduce CBS. The NBB is made of a medical-grade blend of fabric and foam that is latex and neoprene-free and is reported as safe to use on premature infant skin. There are two sizes available and the outer fabric is attached with adjustable Velcro. It is a single baby use and may be hand washed and reused. This device is currently in use in multiple NICUs around the country, and as it has already been FDA-approved for the purpose of our investigation.
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Weeks to 31 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in thickness of the rectus abdominis muscle | 8 weeks | Thickness measured by ultrasound |
Countries
United States
Contacts
CONTACTAndrea Charara, MD
PRINCIPAL_INVESTIGATORSarah Ramel, MD
University of Minnesota
Outcome results
None listed