Imaging Modalities in Diagnosing Necrotizing Enterocolitis in Preterm Infants.

• Conditions: Necrotising Enterocolitis
• Interventions: Diagnostic Test: Plain abdominal radiography; Diagnostic Test: Abdominal ultrasound

• Registration Number: NCT03188380
• Lead Sponsor: Princess Anna Mazowiecka Hospital, Warsaw, Poland

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-11
• Study First Submitted QC: 2017-06-13
• Study First Posted: 2017-06-15
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-12
• Last Update Posted: 2020-05-14
• Study Start: 2021-01-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Abdominal ultrasound (AUS)	Plain abdominal radiography	If plain abdominal radiography is inconclusive or no abnormalities typical for NEC are recorded, an AUS will be ordered.
Plain abdominal radiograph (AR)	Abdominal ultrasound	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.
Plain abdominal radiograph (AR)	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 (AUS)	Abdominal ultrasound	If plain abdominal radiography is inconclusive or no abnormalities typical for NEC are recorded, an AUS will be ordered.

Primary Outcome Measures

Name	Time	Method
Intervention time	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

Secondary Outcome Measures

Name	Time	Method
Sensitivity and specificity	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.

Trial Locations

Locations (1)

Department of Neonatology and Neonatal Intensive Care Warsaw Medical University; 🇵🇱 Warsaw, Poland