Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics

Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics: A Randomized Controlled Trial

Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics

Study Overview

• Status: Recruiting
• Conditions: Brain Injuries
• Intervention / Treatment: Drug: Nucleo CMP Forte

Detailed Description

The study aims to study the Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Tanta, Egypt
    • Recruiting
    • Sherief Abd-Elsalam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children with traumatic brain injury: Moderate and Severe.

Exclusion Criteria:

• Underlying CNS disorders,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nucleo CMP forte; Nucleo CMP forte twice daily for 6 weeks with supportive treatment.	Drug: Nucleo CMP Forte; Nucleo CMP Forte twice daily for 6 weeks; Other Names: Nucleoforte
No Intervention: Supportive treatment; Supportive treatment only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with improved glasgow coma score	The number of patients with improved glasgow coma score	2 months

Collaborators and Investigators

• Sponsor: Sherief Abd-Elsalam
• Investigators: Principal Investigator: Abeer Salamah, Lecturer, Pediatrics department - Kafr-Elsheikh university; Principal Investigator: Mohamed Elbahnasawy, lecturer, Emergency Department- Tanta University.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Anticipated): December 1, 2030
• Study Completion (Anticipated): December 10, 2030

Study Registration Dates

• First Submitted: August 1, 2020
• First Submitted That Met QC Criteria: August 1, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 1, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: KFS protocol

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No