Actively Recruiting

Phase 3
Age: 0 - 1Month
All Genders
ID03966170

Efficacy of Citicoline as Neuroprotector in Preterm; A Randomized Controlled Trial

Led by Sherief Abd-Elsalam · Updated on 2019-05-29

40

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research investigates the use of Citicoline as a neuroprotective agent in preterm infants. The study is a randomized controlled trial aiming to evaluate the effectiveness of Citicoline in protecting the brains of these very young patients. It is a Phase 3 trial focused on improving neurological outcomes in preterm babies. Participants are randomly assigned to receive either Citicoline or a placebo oral tablet. The study includes a blinded design where neither the participants, caregivers, investigators, nor outcome assessors know which treatment is given. This setup is designed to fairly compare the effects of Citicoline against no active drug. During the study, researchers monitor the infants for brain affection at 6 months as the primary outcome measure. The trial involves careful medical assessments and follow-up to evaluate brain health. Participation includes receiving the assigned treatment and undergoing evaluations to track any neurological impact over time until the study's conclusion in December 2028.

CONDITIONS

Brief Title

Citicoline as Neuroprotector in Preterm

Who Can Participate

Age: 0 - 1Month
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Preterm infant on CPAP or ventilator
Not Eligible

You will not qualify if you...

  • Multiple congenital anomalies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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 months

Participants receive either Citicoline or a placebo as neuroprotective treatment.

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

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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