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Ultrasound, Doppler ,and Calprotectin in Necrotizing Enterocolitis Diagnosis

Primary Purpose

Necrotizing Enterocolitis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
fecal calprotectin , doppler and ultrasound
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Necrotizing Enterocolitis

Eligibility Criteria

1 Day - 28 Days (Child)All SexesDoes not accept healthy volunteers

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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Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    intervention arm

    Arm Description

    do fecal calprotectin, doppler and ultrasound for each patient

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    August 14, 2017
    Last Updated
    January 19, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03257553
    Brief Title
    Ultrasound, Doppler ,and Calprotectin in Necrotizing Enterocolitis Diagnosis
    Official Title
    Role of Ultrasound ,Doppler and Calprotectin in Diagnosis of Necrotizing Enterocolitis in Neonates
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2018 (Anticipated)
    Primary Completion Date
    October 2018 (Anticipated)
    Study Completion Date
    April 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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 .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Necrotizing Enterocolitis

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    intervention arm
    Arm Type
    Experimental
    Arm Description
    do fecal calprotectin, doppler and ultrasound for each patient
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    fecal calprotectin , doppler and ultrasound
    Intervention Description
    faecal sample for measurement of calprotectin level ultrasound and doppler
    Primary Outcome Measure Information:
    Title
    diagnosis of necrotizing enterocolitis
    Description
    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
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Day
    Maximum Age & Unit of Time
    28 Days
    Accepts Healthy Volunteers
    No
    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:surgical problems other than NEC ,NEC beyond neonatal period. -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Abdel Latif Abdel Moez, MD
    Phone
    01005208016
    Email
    abdellatefabdelmoez@yahoo.co.uk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ismail Lotfy Mohamad, MD
    Phone
    01063398967
    Email
    drsomaa@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Azhar Arabi, MD
    Organizational Affiliation
    Assiut University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Ultrasound, Doppler ,and Calprotectin in Necrotizing Enterocolitis Diagnosis

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