Back to resultsEfficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics
Primary Purpose
Brain Injuries
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Nucleo CMP Forte
Sponsored by
About this trial
This is an interventional treatment trial for Brain Injuries
Eligibility Criteria
Inclusion Criteria:
- Children with traumatic brain injury: Moderate and Severe.
Exclusion Criteria:
- Underlying CNS disorders,
Sites / Locations
- Sherief Abd-ElsalamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Nucleo CMP forte
Supportive treatment
Arm Description
Nucleo CMP forte twice daily for 6 weeks with supportive treatment.
Supportive treatment only.
Outcomes
Primary Outcome Measures
Number of patients with improved glasgow coma score
The number of patients with improved glasgow coma score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04499755
Brief Title
Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics
Official Title
Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
December 1, 2030 (Anticipated)
Study Completion Date
December 10, 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherief Abd-Elsalam
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics
Detailed Description
The study aims to study the Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nucleo CMP forte
Arm Type
Experimental
Arm Description
Nucleo CMP forte twice daily for 6 weeks with supportive treatment.
Arm Title
Supportive treatment
Arm Type
No Intervention
Arm Description
Supportive treatment only.
Intervention Type
Drug
Intervention Name(s)
Nucleo CMP Forte
Other Intervention Name(s)
Nucleoforte
Intervention Description
Nucleo CMP Forte twice daily for 6 weeks
Primary Outcome Measure Information:
Title
Number of patients with improved glasgow coma score
Description
The number of patients with improved glasgow coma score
Time Frame
2 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children with traumatic brain injury: Moderate and Severe.
Exclusion Criteria:
Underlying CNS disorders,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam, ass. prof.
Phone
00201147773440
Email
sheriefabdelsalam@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abeer Salamah, Lecturer
Organizational Affiliation
Pediatrics department - Kafr-Elsheikh University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed Elbahnasawy, lecturer
Organizational Affiliation
Emergency Department- Tanta University.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sherief Abd-Elsalam
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam, Ass. Prof.
Phone
00201009221243
Email
sheriefabdelsalam@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics
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