Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics

NCT ID: NCT04499755

Last Updated: 2020-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2030-12-10

Brief Summary

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Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics

Detailed Description

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

Conditions

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Brain Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Nucleo CMP forte

Nucleo CMP forte twice daily for 6 weeks with supportive treatment.

Group Type EXPERIMENTAL

Nucleo CMP Forte

Intervention Type DRUG

Nucleo CMP Forte twice daily for 6 weeks

Supportive treatment

Supportive treatment only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Nucleo CMP Forte

Nucleo CMP Forte twice daily for 6 weeks

Intervention Type DRUG

Other Intervention Names

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Nucleoforte

Eligibility Criteria

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Inclusion Criteria

* Children with traumatic brain injury: Moderate and Severe.

Exclusion Criteria

* Underlying CNS disorders,
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sherief Abd-Elsalam

OTHER

Sponsor Role lead

Responsible Party

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Sherief Abd-Elsalam

Ass. Prof. Tropical Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Abeer Salamah, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Pediatrics department - Kafr-Elsheikh University

Mohamed Elbahnasawy, lecturer

Role: PRINCIPAL_INVESTIGATOR

Emergency Department- Tanta University.

Locations

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Sherief Abd-Elsalam

Tanta, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sherief Abd-Elsalam, ass. prof.

Role: CONTACT

00201147773440

Facility Contacts

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Sherief Abd-Elsalam, Ass. Prof.

Role: primary

00201009221243

Other Identifiers

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KFS protocol

Identifier Type: -

Identifier Source: org_study_id

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