Imaging Modalities in Diagnosing Necrotizing Enterocolitis in Preterm Infants.

Study Overview
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Brief Summary
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Background Necrotizing enterocolitis (NEC) is one of the most serious conditions in newborns, affecting up to 10% of very low birth weight infants (VLBW). In the most premature population mortality rates can rise as high as 60%. Typical findings on abdominal radiography (AR) include pnuematosis intestinalis (PI), portal vein gas (PVG) and pneumoperitoneum, but are sometimes not present even in severe cases. Abdominal ultrasound (AUS) can depict PI, PVG and pnuemoperitoneum (in some cases a head 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 expediting diagnosis and management of NEC. Methods and analysis The hypothesis being tested is that preforming an AUR in patients with clinical symptoms of NEC but inconclusive/normal AR will enhance detection rates, and expedite treatment in infants born at <32 weeks. Discussion The use of AUS together with AR as an add-on test may increase the accuracy of diagnosing NEC, and precipitate treatment. Swift implementation of antibiotics and bowel rest is extremely important. To our best knowledge, our study will be the first to focus only on VLBW, who are most prone to NEC. It will also be the first multi-centre study evaluating the use of AUS as an add-on test, enabling us to recruit a significantly higher number of patients compared to published studies.

Official Title
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The Use of Different Imaging Modalities in Diagnosing Necrotizing Enterocolitis in Preterm Infants.

Conditions
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Necrotising Enterocolitis

Intervention / Treatment
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* Diagnostic Test: Plain abdominal radiography
* Diagnostic Test: Abdominal ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Abdominal distension Visible bowels loops Feeding intolerance (defined as emesis ≥ 2 consecutive feeds, or gastric residuals of >50% per feed in ≥ 2 consecutive feeds, bilious residuals, bilious emesis) Temperature instability (defined as ≥ 2 consecutive measurements) Frank bloody stools Cardiovascular instability (hypotension; defined as MAP < 30mmHg, tachycardia >160/' or bradycardia < 80/') Recurrent apnea Increase of abdominal girth > 2cm (allowing inter-observer variability of 1 cm) within 12 h Abdominal wall erythemia And/or at least 2 of the below laboratory findings5: Thrombocytopenia < 50 x103/uL Leukopenia <6 x106/uL CRP > 10 mg/L PCT > 1 ng/ml Coagulopathy Exclusion Criteria: • < 22 weeks of gestational age or > 32 weeks (estimated by ultrasound) Congenital abnormalities No parental consent

Ages Eligible for Study
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Minimum Age: 22 Weeks
Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Plain abdominal radiograph (AR)<br>After meeting enrolment criteria each patient will have an AR performed. One image will be obtained with a vertical beam and a horizontal beam, with the patient supine. | Diagnostic Test: Plain abdominal radiography<br>* After meeting enrolment criteria each patient will have an AR performed. One image will be obtained with a vertical beam and a horizontal beam, with the patient supine.<br>Diagnostic Test: Abdominal ultrasound<br>* If the AR is inconclusive or no abnormalities typical for NEC are recorded, an AUS will be ordered.<br>|
| Abdominal ultrasound (AUS)<br>If plain abdominal radiography is inconclusive or no abnormalities typical for NEC are recorded, an AUS will be ordered. | Diagnostic Test: Plain abdominal radiography<br>* After meeting enrolment criteria each patient will have an AR performed. One image will be obtained with a vertical beam and a horizontal beam, with the patient supine.<br>Diagnostic Test: Abdominal ultrasound<br>* If the AR is inconclusive or no abnormalities typical for NEC are recorded, an AUS will be ordered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention time | The time required to initiate conservative and/or surgical treatment after diagnosing NEC with AR versus AR and AUS | until 40 weeks of post-conceptional age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity | Sensitivity and specificity of a diagnostic strategy involving a combination of AR (reference test) followed by AUS (index test) as compared to AR (reference test) in diagnosing NEC. | until 40 weeks of post-conceptual age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nec, abdominal ultrasound, abdominal radiograph, preterm