Citicoline as Neuroprotector in Preterm

NCT ID: NCT03966170

Last Updated: 2019-05-29

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2028-12-31

Brief Summary

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Citicoline as neuroprotector in preterm

Detailed Description

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Efficacy of Citicoline as neuroprotector in preterm; A randomized controlled trial.

Conditions

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Pre-Term

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Citicoline

Citicoline as neuroprotector

Group Type EXPERIMENTAL

Citicoline

Intervention Type DRUG

Citicoline as neuroprotector

Placebo drug

Placebo

Group Type PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type DRUG

placebo drug

Interventions

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Citicoline

Citicoline as neuroprotector

Intervention Type DRUG

Placebo oral tablet

placebo drug

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Preterm on CPAP or ventilator

Exclusion Criteria

* Multiple congenital anomalies
Maximum Eligible Age

1 Month

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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May R Elsheikh, MD

Role: PRINCIPAL_INVESTIGATOR

Tanta University - Faculty of Medicine

Abeer Salamah, MD

Role: STUDY_DIRECTOR

Kafr-Elsheikh University - Faculty of Medicine

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

Role: primary

Other Identifiers

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Citicoline

Identifier Type: -

Identifier Source: org_study_id

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