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

Part of paid clinical trials in Albany, New York.

Sponsor
Albany Medical College
Study ID
NCT07219784
Status
Enrolling By Invitation

Conditions

  • Abdominal Distension
  • Feeding Intolerance

Eligibility Criteria

Sex
ALL
Age
N/A - 1 Year
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

Start date
Jul 30, 2025
Status verified
Oct 2025
Primary completion
Jun 30, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm with Placement of NeoBellyBand (Abdominal Binder)
    Treatment Arm with Placement of NeoBellyBand (Abdominal Binder): Trained personnel measure the infant's abdominal circumference and place a band that is to be worn for most of the day when the infant is on pressurized breathing support, such as CPAP or NIMV.
  • No Intervention: Control Arm Receiving Standard of Care
    Control Arm Receiving Standard of Care: The control arm will receive the standard of care in the NICU with the exception of additional study measures being collected such as weekly abdominal circumference measurements and data on feeding interruptions.

Primary Outcome Measure

Days with interruptions to the feeding protocol [ Time Frame: During initial hospitalization in the NICU after infant is enrolled in the study (assessed up to 6 months). ]

Locations (1)

FacilityCityStateZIPSite coordinators
Albany Med Health SystemAlbanyNew York12208-

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Albany Med Health System· Albany, NY

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