NEC Screening Abdominal Radiograph vs Bowel Ultrasound in Preemies

NCT03963011 | Terminated Results FDA Device

• 1 other identifier: 17030157
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The overall primary objective is to establish the feasibility and pilot the design and delivery of a diagnostic randomized controlled trial (RCT) of BUS (bowel ultrasound) for NEC evaluation which will lead to a successful application for a larger, multi-center clinical trial in the future. This program of research is anticipated to have a significant positive impact in the timely and accurate diagnosis of NEC in preterm infants.

Conditions

Enterocolitis, Necrotizing; Premature Infant

Keywords

NEC; Necrotizing Enterocolitis; Premature Infant; Calprotectin

Outcome Measures

Primary Outcomes (3)

• Number of Participants Requiring Medical Management

  Evaluate the difference between medical and surgical management between study arms. Medical management is defined as subjects whom did not undergo surgery for their NEC diagnosis. Surgical management is defined as subjects that had a surgical intervention for the NEC diagnosis. Please note that the study was terminated due to low enrollment numbers, thus statistically relevant and applicable numbers cannot be generated from this small study sample.

  First 12 months

• Number of Days Between NEC Diagnosis and Surgical Intervention

  The number of days between NEC diagnosis and surgical intervention for those that need it. Days were continuously counted until subject was discharged from the hospital. Please note that the study was terminated due to low enrollment numbers, thus statistically relevant and applicable numbers cannot be generated from this small study sample.

  12 months

• Number of NPO Days

  Number of nothing by mouth (NPO) days between subject diagnosis of NEC to when subject was placed back on continuous feeds. Please note that the study was terminated due to low enrollment numbers, thus statistically relevant and applicable numbers cannot be generated from this small study sample.

  12 months

Study Arms (2)

Arm A: AXR Only

NO INTERVENTION

Infants randomized to Arm A will obtain an abdominal x-ray (AXR) as per standard of care

Arm B: AXR + Bowel US

ACTIVE COMPARATOR

Infants randomized to Arm B will obtain an abdominal x-ray (AXR) as per standard of care and a bowel ultrasound (BUS) as the intervention

Diagnostic Test: Bowel Ultrasound

Interventions

Bowel Ultrasound DIAGNOSTIC_TEST

Ultrasound imaging of the bowel

Arm B: AXR + Bowel US

Eligibility Criteria

• Age: Up to 28 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates born prior to or at 28 weeks gestation admitted to NICU at CMH

You may not qualify if:

• Infants with chromosomal or multiple congenital anomalies
• Unable to ultrasound the bowel (e.g. gut in silo, omphalocele, gastroschisis)
• Infants who are greater than 36 corrected weeks upon admission

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Related Publications (8)

• Epelman M, Daneman A, Navarro OM, Morag I, Moore AM, Kim JH, Faingold R, Taylor G, Gerstle JT. Necrotizing enterocolitis: review of state-of-the-art imaging findings with pathologic correlation. Radiographics. 2007 Mar-Apr;27(2):285-305. doi: 10.1148/rg.272055098.

  PMID: 17374854 BACKGROUND

• Staryszak J, Stopa J, Kucharska-Miasik I, Osuchowska M, Guz W, Blaz W. Usefulness of ultrasound examinations in the diagnostics of necrotizing enterocolitis. Pol J Radiol. 2015 Jan 1;80:1-9. doi: 10.12659/PJR.890539. eCollection 2015.

  PMID: 25574248 BACKGROUND

• Coursey CA, Hollingsworth CL, Gaca AM, Maxfield C, Delong D, Bisset G 3rd. Radiologists' agreement when using a 10-point scale to report abdominal radiographic findings of necrotizing enterocolitis in neonates and infants. AJR Am J Roentgenol. 2008 Jul;191(1):190-7. doi: 10.2214/ajr.07.3558.

  PMID: 18562745 BACKGROUND

• Coursey CA, Hollingsworth CL, Wriston C, Beam C, Rice H, Bisset G 3rd. Radiographic predictors of disease severity in neonates and infants with necrotizing enterocolitis. AJR Am J Roentgenol. 2009 Nov;193(5):1408-13. doi: 10.2214/AJR.08.2306.

  PMID: 19843760 BACKGROUND

• Faingold R, Daneman A, Tomlinson G, Babyn PS, Manson DE, Mohanta A, Moore AM, Hellmann J, Smith C, Gerstle T, Kim JH. Necrotizing enterocolitis: assessment of bowel viability with color doppler US. Radiology. 2005 May;235(2):587-94. doi: 10.1148/radiol.2352031718.

  PMID: 15858098 BACKGROUND

• Kim WY, Kim WS, Kim IO, Kwon TH, Chang W, Lee EK. Sonographic evaluation of neonates with early-stage necrotizing enterocolitis. Pediatr Radiol. 2005 Nov;35(11):1056-61. doi: 10.1007/s00247-005-1533-4. Epub 2005 Aug 3.

  PMID: 16078076 BACKGROUND

• Nakayuenyongsuk W, Christofferson M, Stevenson DK, Sylvester K, Lee HC, Park KT. Point-of-Care Fecal Calprotectin Monitoring in Preterm Infants at Risk for Necrotizing Enterocolitis. J Pediatr. 2018 May;196:98-103.e1. doi: 10.1016/j.jpeds.2017.12.069. Epub 2018 Mar 6.

  PMID: 29519542 BACKGROUND

• Cuna A, Chan S, Jones J, Sien M, Robinson A, Rao K, Opfer E. Feasibility and acceptability of a diagnostic randomized clinical trial of bowel ultrasound in infants with suspected necrotizing enterocolitis. Eur J Pediatr. 2022 Aug;181(8):3211-3215. doi: 10.1007/s00431-022-04526-4. Epub 2022 Jun 17.

  PMID: 35713688 DERIVED

MeSH Terms

Conditions

Enterocolitis, Necrotizing; Premature Birth

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Limitations and Caveats

Please note that the study was terminated due to low enrollment numbers, thus statistically relevant and applicable numbers cannot be generated from this small study sample.

Results Point of Contact

• Title: Erin Opfer, DO
• Organization: Children's Mercy Hospital

ekopfer@cmh.edu

816-324-3273

Study Officials

• Erin Opfer, DO

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Infants randomized to the AXR only arm will obtain an AXR as per standard of care. Repeat AXR, if any, will be left to the discretion of the treating neonatologist. In this arm, no BUS study will be performed unless the attending neonatologist decides it is clinically indicated. This situation is expected to be exceedingly rare, as BUS is not part of the standard of care for NEC evaluation. Infants randomized to the AXR and BUS arm will also get an AXR, with repeat AXR left to the discretion of the treating neonatologist. In addition to this standard of care, infants randomized to this arm will receive a BUS as the intervention. This BUS will be ordered at the same time as the initial AXR and will be performed within six hours of the order being placed.

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: May 24, 2019
• Study Start: December 20, 2018
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: January 10, 2022
• Results First Posted: January 10, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)