Imaging Modalities in Diagnosing Necrotizing Enterocolitis in Preterm Infants.

Necrotising Enterocolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03188380
• Other study ID #: KAROWA USG VERSION 1.0
• Status: Not yet recruiting
• Start date: January 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2020
• Source: Princess Anna Mazowiecka Hospital, Warsaw, Poland
• Contact: Joanna Seliga-Siwecka, MD PhD
• Phone: +48225966155
• Email: seliga.joanna[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Weeks to 32 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotising Enterocolitis

Intervention

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

Locations

Country	Name	City	State
Poland	Department of Neonatology and Neonatal Intensive Care Warsaw Medical University	Warsaw

Sponsors (4)

Lead Sponsor	Collaborator
Princess Anna Mazowiecka Hospital, Warsaw, Poland	Jagiellonian University, Ujastek Obstetrics and Gynaecology Hospital, University Children’s Hospital of Cracow

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sensitivity and specificity	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