Imaging Modalities in Diagnosing Necrotizing Enterocolitis in Preterm Infants.
The Use of Different Imaging Modalities in Diagnosing Necrotizing Enterocolitis in Preterm Infants.
1 other identifier
observational
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2021
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2017
CompletedFirst Posted
Study publicly available on registry
June 15, 2017
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedMay 14, 2020
May 1, 2020
2 years
May 11, 2017
May 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Sensitivity and specificity
until 40 weeks of post-conceptual age
Study Arms (2)
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.
Interventions
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.
If the AR is inconclusive or no abnormalities typical for NEC are recorded, an AUS will be ordered.
Eligibility Criteria
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:
You may qualify if:
- 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
You may not qualify if:
- \< 22 weeks of gestational age or \> 32 weeks (estimated by ultrasound)
- Congenital abnormalities
- No parental consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Princess Anna Mazowiecka Hospital, Warsaw, Polandlead
- Jagiellonian Universitycollaborator
- Ujastek Obstetrics and Gynaecology Hospitalcollaborator
- University Children's Hospital of Cracowcollaborator
Study Sites (1)
Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
Warsaw, 00-315, Poland
Related Publications (1)
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.
PMID: 32690727DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Renata Bokiniec MD PhD
Study Record Dates
First Submitted
May 11, 2017
First Posted
June 15, 2017
Study Start
January 1, 2021
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
May 14, 2020
Record last verified: 2020-05