Status:
ENROLLING_BY_INVITATION
Abdominal Binders to Minimize Enteral Nutrition Disruptions for Preterm Infants On Non-Invasive Respiratory Support
Lead Sponsor:
Albany Medical College
Conditions:
Feeding Intolerance
Abdominal Distension
Eligibility:
All Genders
Up to 1 years
Phase:
NA
Brief Summary
The goal of this study is to learn if a foam belly strap, called "NeoBellyBand," can help with belly bloating, pauses in feedings, feeding success, and earlier discharge home for preterm infants who a...
Detailed Description
Background Preterm neonates who require respiratory support benefit from the use of non-invasive respiratory support over invasive mechanical ventilation to decrease rates of chronic lung disease \[1\...
Eligibility Criteria
Inclusion
- Born at \<32w0d GA
- Chronologic age \>7 days, treatment or control protocol started by 21 days of life
- On non-invasive positive pressure respiratory support (NIMV or CPAP), either as primary support or after extubation from invasive mechanical ventilation
- Has received 80 mL/kg/day of feeds at least once
Exclusion
- Skin integrity concerns
- Known abdominal or respiratory anomalies
- Umbilical lines in place
- Transferred to AMC NICU after 7 days of life
- Known genetic or major anatomic anomalies
Key Trial Info
Start Date :
July 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07219784
Start Date
July 30 2025
End Date
July 1 2028
Last Update
October 22 2025
Active Locations (1)
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1
Albany Med Health System
Albany, New York, United States, 12208