NCT03188380

Imaging Modalities in Diagnosing Necrotizing Enterocolitis in Preterm Infants.

The Use of Different Imaging Modalities in Diagnosing Necrotizing Enterocolitis in Preterm Infants.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Princess Anna Mazowiecka Hospital, Warsaw, Poland · Academic / Other
• Sex: All
• Age: 22 Weeks – 32 Weeks
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2017-06-15
• Last updated: 2020-05-14

Locations

1 site across 1 country: Poland