Abdominal Binder for Preterm Infants

(ABMENDPIONIR Trial)

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Albany Medical College

Disqualifiers: Skin concerns, Abdominal anomalies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks to 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a foam belly strap, the NeoBellyBand, can assist preterm infants with belly bloating and feeding issues while on breathing support. The study aims to determine if infants wearing the NeoBellyBand experience fewer feeding interruptions compared to those receiving standard NICU care. Eligible infants were born before 32 weeks, have been on pressurized breathing support, and have reached a feeding level of at least 80 mL/kg/day once. Participants will be randomly assigned to either receive the NeoBellyBand or continue with standard NICU care. As an unphased trial, this study provides a unique opportunity to contribute to innovative care solutions for preterm infants.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the NeoBellyBand is safe for preterm infants?

Research shows that the NeoBellyBand is generally safe for premature babies. Studies with this foam belly strap have found no major safety issues. The FDA has approved the NeoBellyBand, indicating it has undergone safety testing in other contexts. Although specific information on side effects for this exact use is limited, the band is designed to be gentle on a baby's skin. It aims to address issues like belly bloating and feeding interruptions without causing harm. Overall, current studies and FDA approval suggest that the NeoBellyBand is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The NeoBellyBand is unique because it offers a new approach to supporting preterm infants using an abdominal binder. Unlike the standard care options, which typically involve pressurized breathing support like CPAP or NIMV, the NeoBellyBand is worn around the baby's abdomen to provide additional stability. Researchers are excited about this treatment because it might reduce feeding interruptions and improve abdominal stability, which could lead to better overall outcomes for these vulnerable infants. By focusing on physical support through a simple band, it targets a different aspect of care that could complement existing respiratory support methods.

What evidence suggests that the NeoBellyBand is effective for reducing feeding interruptions in preterm infants?

Studies have shown that the NeoBellyBand, which participants in this trial may receive, can help reduce belly bloating and improve feeding in premature babies needing breathing support. The band manages "CPAP Belly," a common issue in babies using pressurized breathing assistance. Although information on long-term effects is limited, early research suggests that the NeoBellyBand could lead to fewer disruptions in feeding schedules, potentially resulting in better feeding success and earlier hospital discharge. The FDA has already approved the NeoBellyBand, providing confidence in its safety for use in premature babies. ^{1 3 5 6 7}

Who Is on the Research Team?

Anshu Paul, MD

Principal Investigator

Albany Med Health System

Are You a Good Fit for This Trial?

This trial is for preterm infants experiencing belly bloating and feeding issues while on non-invasive respiratory support. Infants must have parental consent to participate. Specific inclusion or exclusion criteria are not provided, but typically these would relate to the infant's health status and any other treatments they're receiving.

Inclusion Criteria

Has received 80 mL/kg/day of feeds at least once

I am older than 7 days and started treatment before 21 days old.

I was born before 32 weeks of pregnancy.

Exclusion Criteria

Umbilical lines in place

I have issues with my skin's health.

I have known issues with my abdomen or breathing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-3 weeks

1 visit (in-person)

Treatment

Infants are randomly assigned to receive either the NeoBellyBand or standard NICU care. The band is worn for most of the day while on breathing support.

2 weeks to 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including tracking of feeding interruptions and respiratory outcomes.

4 weeks

Data Collection and Analysis

Data on feeding interruptions, abdominal circumference, and respiratory outcomes are collected and analyzed.

What Are the Treatments Tested in This Trial?

Interventions

• NeoBellyBand

Trial Overview The study is testing whether a foam abdominal binder, called 'NeoBellyBand,' can reduce gastrointestinal problems and improve feeding success in preterm infants compared to standard care. Infants will be randomly assigned to either use the NeoBellyBand or receive usual NICU care.

How Is the Trial Designed?

Group I: Treatment Arm with Placement of NeoBellyBand (Abdominal Binder) Experimental Treatment 1 Intervention

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.

Group II: Control Arm Receiving Standard of Care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Albany Medical College

Lead Sponsor

Trials

96

Recruited

12,700+

Citations

1. nature.com nature.com/articles/s41390-025-04557-1

Fat-free mass is associated with neurodevelopment ... Extremely preterm infants represent a highly vulnerable population, facing a high risk of growth faltering and adverse neurodevelopment.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07219784

Abdominal Binders to Minimize Enteral Nutrition ... The goal of this study is to learn if a foam belly strap, called "NeoBellyBand," can help with belly bloating, pauses in feedings, ...

3. withpower.com withpower.com/trial/phase-bronchopulmonary-dysplasia-8-2025-d8b41

NeoBelly Band for Premature Birth 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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1355184125000286

Tactile kinaesthetic methods without abdominal pressure ... TKS has been linked to improved meconium excretion and gastric motility in low birth weight and late preterm infants, though its effect on enteral feeding ...

5. dandlelionmedical.com dandlelionmedical.com/abdominal-distension/

Are you concerned about abdominal distension? - Dandle Ginny McGill discusses her journey with "CPAP Belly," an abdominal distension due to CPAP. She created the NeoBellyBand™ as a form of ...

6. patlynk.com patlynk.com/trial/NCT07049900

Abdominal Binder Study on Abdominal Wall Development ... This study explores whether using a specific type of abdominal band, called the DandleLion NeoBellyBand, can help premature babies who need breathing support.

7. scholars.unh.edu scholars.unh.edu/cgi/viewcontent.cgi?article=2990&context=thesis

A Quality Improvement Project: Increasing Pre-Term Infant ... The intervention involved implementing belly bands in the NICU to support parents during skin-to-skin (STS) contact with their preterm infants. NICU nursing ...