Ultrasound, Doppler ,and Calprotectin in Necrotizing Enterocolitis Diagnosis

Role of Ultrasound ,Doppler and Calprotectin in Diagnosis of Necrotizing Enterocolitis in Neonates

Necrotizing enterocolitis continues to be a disease that is associated with significant morbidity and mortality in premature infants due to advances in neonatal intensive care that increase the survival rate of extremely low birth weight infants (below 1,000 gram)

Study Overview

• Status: Unknown
• Conditions: Necrotizing Enterocolitis
• Intervention / Treatment: Diagnostic test: fecal calprotectin , doppler and ultrasound

Detailed Description

Necrotizing enterocolitis continues to be a disease that is associated with significant morbidity and mortality in premature infants. It affects annually 0.72 infants per 1000 live births among all neonates and 33 infants per 1000 live births among very low-birth-weight (below 1500 gram).

Necrotising enterocolitis presents with both gastrointestinal and systemic signs. Gastrointestinal signs as delayed gastric emptying, abdominal distention and bloody stools. Non specific signs as lethargy, apnea, respiratory distress.

Although clinical and characteristic radiological findings remain the most important tools so far. Unfortunately, these signs are usually detectable in an advanced stage of disease.

• Haematological studies as severe or persistent thrombocytopenia, neutropenia, coagulopathy, or acidosis might indicate severe disease.
• Serial C-reactive protein : that persistently high C-reactive protein indicated developing complications, such as stricture or abscess.

Unfortunately, the majority of these biomarkers lack accuracy in preclinical stage and do not allow proper discrimination from sepsis Therefore, the search for disease-specific, early and noninvasive diagnostic biomarkers remains warranted.

Calprotectin, a peptide secreted by neutrophils and macrophages and is a useful laboratory biomarker for diagnosing necrotizing enterocolitis . Its non-specific biomarkers of inflammation, but the nature of the specimen, e.g. stool, renders these mediators more indicative of the site of tissue injury. And its levels may be a marker for early diagnosis and resolution of gastrointestinal illness , but its utility for early diagnosis and assessment of resolution of necrotizing enterocolitis needs to be studied in a larger studies.

Plain X ray: Definite signs include pneumatosis intestinalis (intramural air) and portal venous gas .

Ultrasound : More sensitive and accurate imaging studies and could become helpful adjuncts to abdominal films in the diagnosis of necrotizing enterocolitis .

The major advantage of sonography over plain abdominal radiography is its superiority in depicting small amount of gas. Ultrasound with Doppler might be more sensitive than abdominal films for detecting necrotic bowel requiring surgical intervention.

When necrotizing enterocolitis is suspected, infants are given bowel rest , bowel decompression, and broad-spectrum antibiotics (after cultures are obtained). Anaerobic coverage should be considered. Adjunctive therapy includes cardiovascular, pulmonary, and haematological support as clinically indicated.

The two main options available for the surgical management of necrotizing enterocolitis are exploratory laparotomy and primary peritoneal drainage .

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abdel Latif Abdel Moez, MD; Phone Number: 01005208016; Email: abdellatefabdelmoez@yahoo.co.uk
• Study Contact Backup: Name: Ismail Lotfy Mohamad, MD; Phone Number: 01063398967; Email: drsomaa@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Include All cases with necrotizing enterocolitis (NEC) in assiut university neonatal intensive care unit (NICU) who are presented with any stage of Bell's stages of necrotising enterocolitis within one year .

I. Suspected disease Mild systemic signs (apnoea, bradycardia, temperature instability) Mild intestinal signs (abdominal distention, gastric residuals, bloody stools) Non-specific or normal radiological signs II. Definite disease Mild to moderate systemic signs Additional intestinal signs (absent bowel sounds, abdominal tenderness) Specific radiologic signs (pneumatosis intestinalis or portal venous air) Laboratory changes (metabolic acidosis, thrombocytopaenia) III. Advanced disease Severe systemic illness (hypotension) Additional intestinal signs (striking abdominal distention, peritonitis) Severe radiological signs (pneumoperitoneum) Additional laboratory changes (metabolic and respiratory acidosis, disseminated intravascular coagulopathy).

Exclusion Criteria:surgical problems other than NEC ,NEC beyond neonatal period.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention arm; do fecal calprotectin, doppler and ultrasound for each patient	Diagnostic test: fecal calprotectin , doppler and ultrasound; faecal sample for measurement of calprotectin level ultrasound and doppler

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnosis of necrotizing enterocolitis	diagnosis of necrotizing enterocolitis by ultrasound, doppler and calprotectin and compare to see more sensitive and specific method of them in comparison with plain erect	one year

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Azhar Arabi, MD, Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2018
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): April 1, 2019

Study Registration Dates

• First Submitted: August 14, 2017
• First Submitted That Met QC Criteria: August 18, 2017
• First Posted (Actual): August 22, 2017

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 19, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Enterocolitis; Enterocolitis, Necrotizing
• Other Study ID Numbers: UDFNEC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No