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Imaging Modalities in Diagnosing Necrotizing Enterocolitis in Preterm Infants.

NCT03188380 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2020-05-14

No results posted yet for this study

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.

Conditions

  • Necrotising Enterocolitis

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

Abdominal ultrasound

If the AR is inconclusive or no abnormalities typical for NEC are recorded, an AUS will be ordered.

Sponsors & Collaborators

  • Jagiellonian University

    collaborator OTHER

  • Ujastek Obstetrics and Gynaecology Hospital

    collaborator UNKNOWN

  • University Children's Hospital of Cracow

    collaborator UNKNOWN

  • Princess Anna Mazowiecka Hospital, Warsaw, Poland

    lead OTHER

Eligibility

Min Age
22 Weeks
Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Poland

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03188380 on ClinicalTrials.gov