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| Name | Class |
|---|---|
| Jagiellonian University | OTHER |
| Ujastek Obstetrics and Gynaecology Hospital | UNKNOWN |
| University Children's Hospital of Cracow | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plain abdominal radiograph (AR) | 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. |
| |
| Abdominal ultrasound (AUS) | If plain abdominal radiography is inconclusive or no abnormalities typical for NEC are recorded, an AUS will be ordered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plain abdominal radiography | Diagnostic Test | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
And/or at least 2 of the below laboratory findings5:
Exclusion Criteria:
• < 22 weeks of gestational age or > 32 weeks (estimated by ultrasound)
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In this single-gate study we plan to include all consecutive preterm infants (born at <32 weeks of gestation) with suspected necrotizing enterocolitis based on the presence of at least three of the above mentioned clinical symptoms 4-7:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joanna Seliga-Siwecka, MD PhD | Contact | +48225966155 | seliga.joanna@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neonatology and Neonatal Intensive Care Warsaw Medical University | Warsaw | 00-315 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32690727 | Derived | Seliga-Siwecka J, Rutkowski J, Margas W, Puskarz-Gasowska J, Bokiniec R. Sensitivity and specificity of different imaging modalities in diagnosing necrotising enterocolitis in a Polish population of preterm infants: a diagnostic test accuracy study protocol. BMJ Open. 2020 Jul 20;10(7):e033519. doi: 10.1136/bmjopen-2019-033519. |
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All de-identified data collected during the trial will be available. The study protocol will also be available. These documents will be accessible to anyone who provides a methodologically sound proposal immediately following publication with no end date.
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| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Abdominal ultrasound | Diagnostic Test | If the AR is inconclusive or no abnormalities typical for NEC are recorded, an AUS will be ordered. |
|
| D007410 |
| Intestinal Diseases |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |