<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03257553</url>
  </required_header>
  <id_info>
    <org_study_id>UDFNEC</org_study_id>
    <nct_id>NCT03257553</nct_id>
  </id_info>
  <brief_title>Ultrasound, Doppler ,and Calprotectin in Necrotizing Enterocolitis Diagnosis</brief_title>
  <official_title>Role of Ultrasound ,Doppler and Calprotectin in Diagnosis of Necrotizing Enterocolitis in Neonates</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Necrotizing enterocolitis continues to be a disease that is associated with significant&#xD;
      morbidity and mortality in premature infants due to advances in neonatal intensive care that&#xD;
      increase the survival rate of extremely low birth weight infants (below 1,000 gram)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Necrotizing enterocolitis continues to be a disease that is associated with significant&#xD;
      morbidity and mortality in premature infants. It affects annually 0.72 infants per 1000 live&#xD;
      births among all neonates and 33 infants per 1000 live births among very low-birth-weight&#xD;
      (below 1500 gram).&#xD;
&#xD;
      Necrotising enterocolitis presents with both gastrointestinal and systemic signs.&#xD;
      Gastrointestinal signs as delayed gastric emptying, abdominal distention and bloody stools.&#xD;
      Non specific signs as lethargy, apnea, respiratory distress.&#xD;
&#xD;
      Although clinical and characteristic radiological findings remain the most important tools so&#xD;
      far. Unfortunately, these signs are usually detectable in an advanced stage of disease.&#xD;
&#xD;
        -  Haematological studies as severe or persistent thrombocytopenia, neutropenia,&#xD;
           coagulopathy, or acidosis might indicate severe disease.&#xD;
&#xD;
        -  Serial C-reactive protein : that persistently high C-reactive protein indicated&#xD;
           developing complications, such as stricture or abscess.&#xD;
&#xD;
      Unfortunately, the majority of these biomarkers lack accuracy in preclinical stage and do not&#xD;
      allow proper discrimination from sepsis Therefore, the search for disease-specific, early and&#xD;
      noninvasive diagnostic biomarkers remains warranted.&#xD;
&#xD;
      Calprotectin, a peptide secreted by neutrophils and macrophages and is a useful laboratory&#xD;
      biomarker for diagnosing necrotizing enterocolitis . Its non-specific biomarkers of&#xD;
      inflammation, but the nature of the specimen, e.g. stool, renders these mediators more&#xD;
      indicative of the site of tissue injury. And its levels may be a marker for early diagnosis&#xD;
      and resolution of gastrointestinal illness , but its utility for early diagnosis and&#xD;
      assessment of resolution of necrotizing enterocolitis needs to be studied in a larger&#xD;
      studies.&#xD;
&#xD;
      Plain X ray: Definite signs include pneumatosis intestinalis (intramural air) and portal&#xD;
      venous gas .&#xD;
&#xD;
      Ultrasound : More sensitive and accurate imaging studies and could become helpful adjuncts to&#xD;
      abdominal films in the diagnosis of necrotizing enterocolitis .&#xD;
&#xD;
      The major advantage of sonography over plain abdominal radiography is its superiority in&#xD;
      depicting small amount of gas. Ultrasound with Doppler might be more sensitive than abdominal&#xD;
      films for detecting necrotic bowel requiring surgical intervention.&#xD;
&#xD;
      When necrotizing enterocolitis is suspected, infants are given bowel rest , bowel&#xD;
      decompression, and broad-spectrum antibiotics (after cultures are obtained). Anaerobic&#xD;
      coverage should be considered. Adjunctive therapy includes cardiovascular, pulmonary, and&#xD;
      haematological support as clinically indicated.&#xD;
&#xD;
      The two main options available for the surgical management of necrotizing enterocolitis are&#xD;
      exploratory laparotomy and primary peritoneal drainage .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">April 2018</start_date>
  <completion_date type="Anticipated">April 2019</completion_date>
  <primary_completion_date type="Anticipated">October 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>diagnosis of necrotizing enterocolitis</measure>
    <time_frame>one year</time_frame>
    <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</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Necrotizing Enterocolitis</condition>
  <arm_group>
    <arm_group_label>intervention arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>do fecal calprotectin, doppler and ultrasound for each patient</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>fecal calprotectin , doppler and ultrasound</intervention_name>
    <description>faecal sample for measurement of calprotectin level ultrasound and doppler</description>
    <arm_group_label>intervention arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Include All cases with necrotizing enterocolitis (NEC) in assiut university neonatal&#xD;
             intensive care unit (NICU) who are presented with any stage of Bell's stages of&#xD;
             necrotising enterocolitis within one year .&#xD;
&#xD;
        I. Suspected disease Mild systemic signs (apnoea, bradycardia, temperature instability)&#xD;
        Mild intestinal signs (abdominal distention, gastric residuals, bloody stools) Non-specific&#xD;
        or normal radiological signs II. Definite disease Mild to moderate systemic signs&#xD;
        Additional intestinal signs (absent bowel sounds, abdominal tenderness) Specific radiologic&#xD;
        signs (pneumatosis intestinalis or portal venous air) Laboratory changes (metabolic&#xD;
        acidosis, thrombocytopaenia) III. Advanced disease Severe systemic illness (hypotension)&#xD;
        Additional intestinal signs (striking abdominal distention, peritonitis) Severe&#xD;
        radiological signs (pneumoperitoneum) Additional laboratory changes (metabolic and&#xD;
        respiratory acidosis, disseminated intravascular coagulopathy).&#xD;
&#xD;
        Exclusion Criteria:surgical problems other than NEC ,NEC beyond neonatal period.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>28 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Azhar Arabi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Abdel Latif Abdel Moez, MD</last_name>
    <phone>01005208016</phone>
    <email>abdellatefabdelmoez@yahoo.co.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ismail Lotfy Mohamad, MD</last_name>
    <phone>01063398967</phone>
    <email>drsomaa@yahoo.com</email>
  </overall_contact_backup>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>January 19, 2018</last_update_submitted>
  <last_update_submitted_qc>January 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Azhar Arabi mohammed</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Enterocolitis</mesh_term>
    <mesh_term>Enterocolitis, Necrotizing</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03257553
org study id: UDFNEC
nct id: NCT03257553
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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)
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 .
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: diagnosis of necrotizing enterocolitis
time frame: one year
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
arm group label: intervention arm
arm group type: Experimental
description: do fecal calprotectin, doppler and ultrasound for each patient
intervention type: Diagnostic Test
intervention name: fecal calprotectin , doppler and ultrasound
description: faecal sample for measurement of calprotectin level ultrasound and doppler
arm group label: intervention arm
criteria: 
gender: All
minimum age: 1 Day
maximum age: 28 Days
healthy volunteers: No
last name: Azhar Arabi, MD
role: Principal Investigator
affiliation: Assiut University
last name: Abdel Latif Abdel Moez, MD
phone: 01005208016
email: abdellatefabdelmoez@yahoo.co.uk
last name: Ismail Lotfy Mohamad, MD
phone: 01063398967
email: drsomaa@yahoo.com
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Azhar Arabi mohammed
investigator title: principal investigator
mesh term: Enterocolitis
mesh term: Enterocolitis, Necrotizing