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

NCT07219784 | Enrolling By Invitation FDA Device

• 1 other identifier: 7227
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 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

Keywords

Feeding Intolerance in Neonates; CPAP Belly; Abdominal Distension from CPAP or NIMV; Feeding Disruption from Abdominal Distension; NeoBellyBand; Abdominal Binder to Minimize Feeding Disruption

Outcome Measures

Primary Outcomes (1)

• Days with interruptions to the feeding protocol

  Days with interruptions to the feeding protocol, defined as interruptions to feeds or advances per our unit protocol for the infant's GA and birth weight (BW), due to feeding intolerance, defined as abdominal distension, increase in abdominal girth, abnormal stooling pattern, abdominal tenderness, increase in gastric residuals, emesis, and feeding-related cardiorespiratory events.

  During initial hospitalization in the NICU after infant is enrolled in the study (assessed up to 6 months).

Secondary Outcomes (7)

• Age at which infant first achieved 120 mL/kg/day of enteral feeds

  During initial hospitalization in the NICU after infant is enrolled in the study (assessed up to 6 months).

• Number of abdominal radiographs obtained for abdominal concerns

  During initial hospitalization in the NICU after infant is enrolled in the study (assessed up to 6 months).

• Length of hospital admission and post-menstrual age (PMA) at discharge

  During initial hospitalization in the NICU after infant is enrolled in the study.

• Rates of chronic lung disease (CLD), defined as oxygen requirement at 36 weeks PMA

  During initial hospitalization in the NICU after infant is enrolled in the study (assessed up to 6 months).

• Post-menstrual age (PMA) when successfully off all respiratory support

  During initial hospitalization in the NICU after infant is enrolled in the study (assessed up to 6 months).

Study Arms (2)

Treatment Arm with Placement of NeoBellyBand (Abdominal Binder)

EXPERIMENTAL

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.

Device: An abdominal binder

Control Arm Receiving Standard of Care

NO 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.

Interventions

An abdominal binder DEVICE

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

Treatment Arm with Placement of NeoBellyBand (Abdominal Binder)

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Albany Medical College: lead

Study Sites (1)

Albany Med Health System

Albany, New York, 12208, United States

Location

Related Publications (7)

• McGill VE. Neonatal abdominal support to address CPAP belly: Two cases report and literature review. J Neonatal Perinatal Med. 2022;15(4):831-836. doi: 10.3233/NPM-221047.

  PMID: 36031911 BACKGROUND

• Seiiedi-Biarag L, Mirghafourvand M. The effect of massage on feeding intolerance in preterm infants: a systematic review and meta-analysis study. Ital J Pediatr. 2020 Apr 23;46(1):52. doi: 10.1186/s13052-020-0818-4.

  PMID: 32326971 BACKGROUND

• Ortigoza EB. Feeding intolerance. Early Hum Dev. 2022 Aug;171:105601. doi: 10.1016/j.earlhumdev.2022.105601. Epub 2022 Jun 10. No abstract available.

  PMID: 35728504 BACKGROUND

• Gu H, Seekins J, Ritter V, Halamek LP, Wall JK, Fuerch JH. Characterizing continuous positive airway pressure (CPAP) Belly Syndrome in preterm infants in the neonatal intensive care unit (NICU). J Perinatol. 2024 Sep;44(9):1269-1275. doi: 10.1038/s41372-024-01918-2. Epub 2024 Mar 6.

  PMID: 38448640 BACKGROUND

• Gounaris A, Costalos C, Varchalama L, Kokori P, Kolovou E, Alexiou N. Gastric emptying in very-low-birth-weight infants treated with nasal continuous positive airway pressure. J Pediatr. 2004 Oct;145(4):508-10. doi: 10.1016/j.jpeds.2004.06.030.

  PMID: 15480376 BACKGROUND

• Jaile JC, Levin T, Wung JT, Abramson SJ, Ruzal-Shapiro C, Berdon WE. Benign gaseous distension of the bowel in premature infants treated with nasal continuous airway pressure: a study of contributing factors. AJR Am J Roentgenol. 1992 Jan;158(1):125-7. doi: 10.2214/ajr.158.1.1727337.

  PMID: 1727337 BACKGROUND

• Shukla VV, Ambalavanan N. Recent Advances in Bronchopulmonary Dysplasia. Indian J Pediatr. 2021 Jul;88(7):690-695. doi: 10.1007/s12098-021-03766-w. Epub 2021 May 20.

  PMID: 34018135 BACKGROUND

Study Officials

• Anshu Paul, MD

  Albany Med Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Of Pediatrics

Model Details: This is a randomized controlled trial of hospitalized preterm neonates born less than 32 weeks and 0 days gestational age (GA) on non-invasive respiratory support to evaluate respiratory and enteral nutrition outcomes of infants using abdominal binders compared with infants who are not using them.

Study Record Dates

• First Submitted: October 21, 2025
• First Posted: October 22, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: October 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)