Abdominal Binders to Minimize Enteral Nutrition Disruptions for Preterm Infants On Non-Invasive Respiratory Support

Enrolling by invitation · Not applicable

Conditions studied: Feeding Intolerance, Abdominal Distension

In brief

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 are requiring pressurized breathing support. Infants whose parents/ caregivers have consented to the study will be randomly chosen with a 50/50 chance of treatment with the NeoBellyBand or receiving standard NICU care. The main question it seeks to answer is if there are less interruptions to the feeding protocol for infants who have a NeoBellyBand placed on them compared with infants who do not. Infants on the treatment arm will have their bellies measured by trained personnel and have bands placed on them, which will be worn for most of the day while on breathing support with pressure.

Key facts

Study ID

NCT07219784

Run by

Albany Medical College

People needed

120

Starts

2025-07-30

Expected to finish

2028-07-01

Last updated by the study team

2025-10-22

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Albany Med Health System — Albany, New York, United States

Full record on ClinicalTrials.gov

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