Ultrasound, Doppler ,and Calprotectin in Necrotizing Enterocolitis Diagnosis

NCT ID: NCT03257553

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-30
• Study Completion Date: 2019-04-30

Brief Summary

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)

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 .

Conditions

Necrotizing Enterocolitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

intervention arm

do fecal calprotectin, doppler and ultrasound for each patient

Group Type: EXPERIMENTAL

fecal calprotectin , doppler and ultrasound

Intervention Type: DIAGNOSTIC_TEST

faecal sample for measurement of calprotectin level ultrasound and doppler

Interventions

fecal calprotectin , doppler and ultrasound

faecal sample for measurement of calprotectin level ultrasound and doppler

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

-

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Azhar Arabi mohammed

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Azhar Arabi, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

Abdel Latif Abdel Moez, MD

Role: CONTACT

abdellatefabdelmoez@yahoo.co.uk

01005208016

Ismail Lotfy Mohamad, MD

Role: CONTACT

drsomaa@yahoo.com

01063398967

Other Identifiers

UDFNEC

Identifier Type: -

Identifier Source: org_study_id