Sensitivity and specificity of different imaging modalities in diagnosing necrotising enterocolitis in a Polish population of preterm infants: a diagnostic test accuracy study protocol

Joanna Seliga-Siwecka, Jakub Rutkowski, Wojciech Margas, Joanna Puskarz-Gąsowska, Renata Bokiniec, Joanna Seliga-Siwecka, Jakub Rutkowski, Wojciech Margas, Joanna Puskarz-Gąsowska, Renata Bokiniec

Abstract

Introduction: Necrotising enterocolitis (NEC) is one of the most serious conditions in newborn infants, affecting up to 10% of very low birth weight (VLBW) infants. Mortality rates can rise as high as 60%.The suspected diagnosis is confirmed with typical findings on abdominal radiography (AR) such as pneumatosis intestinalis (PI), portal vein gas (PVG) and in extreme cases pneumoperitoneum. Abdominal ultrasound (AUS) can depict PI, PVG and pnuemoperitoneum (in some cases ahead of AR), but it also provides other crucial information such as bowel wall viability (thickness or thinning) and free abdominal fluid. These additional findings are helpful in diagnosing and managing NEC.

Methods and analysis: The hypothesis being tested is that preforming an AR in patients with clinical symptoms of NEC, but inconclusive/normal AR will enhance detection rates, and expedite treatment in infants born at <32 weeks. Additionally, the time needed to initiate treatment, according to decision made based on AR or AR and AUS will also be compared. The use of AUS together with AR as an add-on test may increase the accuracy of diagnosing NEC and expedite life-saving treatment. We plan to recruit 200 VLBW infants, who are most prone to NEC. It will also be the first multicentre study evaluating the use of AUS as an add-on test, enabling us to recruit a significantly higher number of patients compared with published studies.

Ethics and dissemination: The Bioethical Committee of the Medical University of Warsaw has approved the study (KB 130/2017). We plan to submit our findings to international peer-reviewed journals. Abstract will be submitted to local and international conferences.

Trial registration number: NCT03188380; Protocol version: V.2.08.2019; Pre-results.

Keywords: necrotising enterocolitis; preterm infant; ultrasound.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Analytical framework for the evaluation of abdominal ultrasound and plain radiography.
Figure 2
Figure 2
Diagnostic decision tree for AUS as an add-on test. AUS, abdominal ultrasound; AR, abdominal radiograph; NEC, necrotising enterocolitis; PVG, portal vein gas; PI, pneumatosis intestinalis.

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