Actively Recruiting

Phase 3
Age: 0 - 18Years
All Genders
ID04499755

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

Led by Sherief Abd-Elsalam · Updated on 2020-08-05

100

Participants Needed

1

Research Sites

1 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the effectiveness of Nucleo CMP Forte in children with moderate to severe traumatic brain injury. The study is a randomized controlled trial designed to assess whether this treatment can improve outcomes in pediatric brain injury patients. Participants are divided into two groups: one group receives Nucleo CMP Forte twice daily for 6 weeks along with supportive treatment, while the other group receives supportive treatment alone. This comparison will help determine the potential benefits of adding Nucleo CMP Forte to standard care. Children taking part in the trial will be monitored over a period of two months to assess improvements in their Glasgow Coma Score, which measures their level of consciousness after brain injury. Researchers will evaluate how many patients show improvement, with ongoing safety and health assessments throughout the study period.

CONDITIONS

Brief Title

Efficacy of Nucleo CMP Forte in Traumatic Brain Injury in Pediatrics

Who Can Participate

Age: 0 - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children with moderate or severe traumatic brain injury
Not Eligible

You will not qualify if you...

  • Presence of underlying central nervous system (CNS) disorders

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 6 weeks

Participants receive Nucleo CMP Forte twice daily for 6 weeks along with supportive treatment or supportive treatment only.

Twice daily dosing for 6 weeks

Trial Site Locations

Total: 1 location

1

Sherief Abd-Elsalam

Tanta, Egypt

Actively Recruiting

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Research Team

S

Sherief Abd-Elsalam, ass. prof.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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