Baby ABS (Abdominal Binder Study)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age26-31
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
Qualifiers
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.
Disqualifiers
Outside of gestational age at birth
Umbilical lines
Genetic condition or neuromuscular anomaly
Known abdominal anomaly
Trial design
Treatments tested in this trial
- NeoBelly Band
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov