<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/NCT04499755</url>
  </required_header>
  <id_info>
    <org_study_id>KFS protocol</org_study_id>
    <nct_id>NCT04499755</nct_id>
  </id_info>
  <brief_title>Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics</brief_title>
  <official_title>Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sherief Abd-Elsalam</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tanta University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study aims to study the Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in&#xD;
      Pediatrics&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">December 10, 2030</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2030</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with improved glasgow coma score</measure>
    <time_frame>2 months</time_frame>
    <description>The number of patients with improved glasgow coma score</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Brain Injuries</condition>
  <arm_group>
    <arm_group_label>Nucleo CMP forte</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nucleo CMP forte twice daily for 6 weeks with supportive treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Supportive treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Supportive treatment only.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nucleo CMP Forte</intervention_name>
    <description>Nucleo CMP Forte twice daily for 6 weeks</description>
    <arm_group_label>Nucleo CMP forte</arm_group_label>
    <other_name>Nucleoforte</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children with traumatic brain injury: Moderate and Severe.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Underlying CNS disorders,&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abeer Salamah, Lecturer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pediatrics department - Kafr-Elsheikh University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohamed Elbahnasawy, lecturer</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emergency Department- Tanta University.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sherief Abd-Elsalam, ass. prof.</last_name>
    <phone>00201147773440</phone>
    <email>sheriefabdelsalam@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sherief Abd-Elsalam</name>
      <address>
        <city>Tanta</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sherief Abd-Elsalam, Ass. Prof.</last_name>
      <phone>00201009221243</phone>
      <email>sheriefabdelsalam@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 1, 2020</study_first_submitted>
  <study_first_submitted_qc>August 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>August 1, 2020</last_update_submitted>
  <last_update_submitted_qc>August 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Tanta University</investigator_affiliation>
    <investigator_full_name>Sherief Abd-Elsalam</investigator_full_name>
    <investigator_title>Ass. Prof. Tropical Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04499755
org study id: KFS protocol
nct id: NCT04499755
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics
The study aims to study the Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in
      Pediatrics
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Number of patients with improved glasgow coma score
time frame: 2 months
description: The number of patients with improved glasgow coma score
arm group label: Nucleo CMP forte
arm group type: Experimental
description: Nucleo CMP forte twice daily for 6 weeks with supportive treatment.
arm group label: Supportive treatment
arm group type: No Intervention
description: Supportive treatment only.
intervention type: Drug
intervention name: Nucleo CMP Forte
description: Nucleo CMP Forte twice daily for 6 weeks
arm group label: Nucleo CMP forte
other name: Nucleoforte
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Abeer Salamah, Lecturer
role: Principal Investigator
affiliation: Pediatrics department - Kafr-Elsheikh University
last name: Mohamed Elbahnasawy, lecturer
role: Principal Investigator
affiliation: Emergency Department- Tanta University.
last name: Sherief Abd-Elsalam, ass. prof.
phone: 00201147773440
email: sheriefabdelsalam@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Tanta University
investigator full name: Sherief Abd-Elsalam
investigator title: Ass. Prof. Tropical Medicine
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Wounds and Injuries
sharing ipd: No