- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03966170
Citicoline as Neuroprotector in Preterm
May 24, 2019 updated by: Sherief Abd-Elsalam
Efficacy of Citicoline as Neuroprotector in Preterm; A Randomized Controlled Trial
Citicoline as neuroprotector in preterm
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Efficacy of Citicoline as neuroprotector in preterm; A randomized controlled trial.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tanta, Egypt
- Recruiting
- Sherief Abd-Elsalam
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 1 month (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Preterm on CPAP or ventilator
Exclusion Criteria:
- Multiple congenital anomalies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo drug
Placebo
|
placebo drug
|
EXPERIMENTAL: Citicoline
Citicoline as neuroprotector
|
Citicoline as neuroprotector
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of children with affection of the brain
Time Frame: 6 months
|
Number of children with affection of the brain
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: May R Elsheikh, MD, Tanta university - faculty of medicine
- Study Director: Abeer Salamah, MD, Kafr-Elsheikh University - Faculty of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 1, 2019
Primary Completion (ANTICIPATED)
November 1, 2028
Study Completion (ANTICIPATED)
December 1, 2028
Study Registration Dates
First Submitted
May 24, 2019
First Submitted That Met QC Criteria
May 24, 2019
First Posted (ACTUAL)
May 29, 2019
Study Record Updates
Last Update Posted (ACTUAL)
May 29, 2019
Last Update Submitted That Met QC Criteria
May 24, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Citicoline
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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