NCT03963011

NEC Screening Abdominal Radiograph vs Bowel Ultrasound in Preemies

Terminated NA Results posted Last updated 10 January 2022

What this trial tests

NA trial testing Bowel Ultrasound in Enterocolitis, Necrotizing in 56 participants. Terminated before completion.

Timeline

20 December 2018

Primary endpoint
1 October 2020

1 October 2020

Quick facts

Lead sponsor	Children's Mercy Hospital Kansas City
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	56
Start date	20 December 2018
Primary completion	1 October 2020
Estimated completion	1 October 2020
Sites	1 location across United States

Drugs / interventions tested

• Bowel Ultrasound

Conditions studied

• Enterocolitis, Necrotizing — all drugs for Enterocolitis, Necrotizing →
• Premature Infant — all drugs for Premature Infant →

Sponsor

Children's Mercy Hospital Kansas City

Who can join

Under 28 Weeks, any sex, with Enterocolitis, Necrotizing or Premature Infant. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Requiring Medical Management Primary · First 12 months

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.

Group	Value	95% CI
Arm A: AXR Only	1
Arm B: AXR + Bowel US	1

Number of Days Between NEC Diagnosis and Surgical Intervention Primary · 12 months

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.

Group	Value	95% CI
Arm B: AXR + Bowel US	10	0 – 20

Number of NPO Days Primary · 12 months

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.

Group	Value	95% CI
Arm A: AXR Only	4	± 3.6
Arm B: AXR + Bowel US	7	± 1.6

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Feasibility and acceptability of a diagnostic randomized clinical trial of bowel ultrasound in infants with suspected necrotizing enterocolitis.
   Cuna A, Chan S, Jones J, Sien M, et al · · 2022 · cited 9× · PMID 35713688 · DOI 10.1007/s00431-022-04526-4