Imaging Modalities in Diagnosing Necrotizing Enterocolitis in Preterm Infants.

May 12, 2020 updated by: Renata Bokiniec, Princess Anna Mazowiecka Hospital, Warsaw, Poland

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

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Warsaw, Poland, 00-315
        • Department of Neonatology and Neonatal Intensive Care Warsaw Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 7 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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:

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2021

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

May 11, 2017

First Submitted That Met QC Criteria

June 13, 2017

First Posted (ACTUAL)

June 15, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 14, 2020

Last Update Submitted That Met QC Criteria

May 12, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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