Imaging Modalities in Diagnosing Necrotizing Enterocolitis in Preterm Infants.
NCT ID: NCT03188380
Last Updated: 2020-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2021-01-01
2022-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Plain abdominal radiography
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
If the AR is inconclusive or no abnormalities typical for NEC are recorded, an AUS will be ordered.
Abdominal ultrasound (AUS)
If plain abdominal radiography is inconclusive or no abnormalities typical for NEC are recorded, an AUS will be ordered.
Plain abdominal radiography
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
If the AR is inconclusive or no abnormalities typical for NEC are recorded, an AUS will be ordered.
Interventions
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Plain abdominal radiography
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
If the AR is inconclusive or no abnormalities typical for NEC are recorded, an AUS will be ordered.
Eligibility Criteria
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Inclusion Criteria
* 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
* Congenital abnormalities
* No parental consent
22 Weeks
32 Weeks
ALL
No
Sponsors
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Jagiellonian University
OTHER
Ujastek Obstetrics and Gynaecology Hospital
UNKNOWN
University Children's Hospital of Cracow
UNKNOWN
Princess Anna Mazowiecka Hospital, Warsaw, Poland
OTHER
Responsible Party
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Renata Bokiniec
Renata Bokiniec MD PhD
Locations
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Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
Warsaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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Joanna Seliga-Siwecka
Role: backup
References
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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.
Other Identifiers
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KAROWA USG VERSION 1.0
Identifier Type: -
Identifier Source: org_study_id
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