- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03188380
Imaging Modalities in Diagnosing Necrotizing Enterocolitis in Preterm Infants.
The Use of Different Imaging Modalities in Diagnosing Necrotizing Enterocolitis in Preterm Infants.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Warsaw, Poland, 00-315
- Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
-
Contact:
- Joanna Seliga-Siwecka, MD PhD
- Phone Number: +48225966155
- Email: joanna.seliga@wum.edu.pl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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.
|
Abdominal ultrasound (AUS)
If plain abdominal radiography is inconclusive or no abnormalities typical for NEC are recorded, an AUS will be ordered.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intervention time
Time Frame: until 40 weeks of post-conceptional age
|
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
Time Frame: until 40 weeks of post-conceptual age
|
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
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KAROWA USG VERSION 1.0
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Necrotising Enterocolitis
-
University Hospitals of Derby and Burton NHS Foundation...University of NottinghamRecruitingNecrotising Enterocolitis NeonatalUnited Kingdom
-
Ain Shams UniversityCompleted
-
Zeynep Kamil Maternity and Pediatric Research and...Completed
-
Zekai Tahir Burak Women's Health Research and Education...UnknownTransfusion | Feeding During Transfusion | Transfusion Related Acute Gut Injury | Necrotising EnterocolitisTurkey
-
Princess Anna Mazowiecka Hospital, Warsaw, PolandNot yet recruitingDeath | Growth | Necrotising Enterocolitis | Duct Dependent LesionsPoland
-
Rigshospitalet, DenmarkOdense University Hospital; Technical University of DenmarkNot yet recruitingPreterm Infants | Atresia; Bowel | Term Infants | Innate Inflammatory Response | Necrotising EnterocolitisDenmark
-
Emma Marie Caroline SlackUniversity of Zurich; University Children's Hospital, ZurichCompletedLate-Onset Neonatal Sepsis | Necrotising EnterocolitisSwitzerland
-
Ankara UniversityCompletedVery Low Birth Weight Infants | Necrotising Enterocolitis | Late Onset Neonatal SepsisTurkey
-
University College DublinWellcome Trust; Health Research Board, Ireland; National Maternity Hospital,... and other collaboratorsRecruitingLate-Onset Neonatal Sepsis | Necrotising Enterocolitis | Culture Negative Neonatal SepsisIreland
-
Gorm GreisenCompletedComplications | NEC - Necrotizing EnterocolitisDenmark
Clinical Trials on Plain abdominal radiography
-
Chonnam National University HospitalCompleted
-
University Hospital, GenevaCompletedEmergencies | Abdomen, Acute | Diagnostic ImagingSwitzerland
-
Mayo ClinicCompletedTubal SterilizationUnited States
-
Centre Hospitalier Régional d'OrléansCompleted
-
Washington University School of MedicineAgency for Healthcare Research and Quality (AHRQ)CompletedHealth Literacy | Health Insurance | Health Services AccessibilityUnited States
-
Ramsay Générale de SantéEuropean Clinical Trial Experts Network; Private Hospital Jean MermozRecruitingKnee Injuries | ACL | ALL | Anterior Curciate Ligament | Anterolateral LigamentFrance
-
Centre Hospitalier Universitaire DijonUnknown
-
Balgrist University HospitalCompletedCongenital Medial DeviationSwitzerland
-
National Cancer Institute (NCI)Active, not recruiting
-
Nanfang Hospital, Southern Medical UniversityRecruiting