Baby ABS (Abdominal Binder Study)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-31
SponsorUniversity of Minnesota
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Outside of gestational age at birth
Umbilical lines
Genetic condition or neuromuscular anomaly
Known abdominal anomaly
Trial design
Design model
Parallel
Treatments tested in this trial
NeoBelly Band
DeviceThe 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: NeoBelllyBandActive comparator 1 intervention
Group B: Standard NICU CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in thickness of the rectus abdominis muscle
Thickness measured by ultrasound
Time frame
8 weeksSponsors and contacts
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Source ClinicalTrials.gov