MedTrace Logo

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

NCT07219784 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-10-22

No results posted yet for this study

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 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.

Conditions

  • Feeding Intolerance
  • Abdominal Distension

Interventions

DEVICE

An abdominal binder

This study involves the placement of an abdominal binder for preterm infants on non-invasive pressure breathing support.

Sponsors & Collaborators

  • Albany Medical College

    lead OTHER

Principal Investigators

  • Anshu Paul, MD · Albany Med Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-30
Primary Completion
2028-06-30
Completion
2028-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07219784 on ClinicalTrials.gov