Back to resultsCiticoline as Neuroprotector in Preterm
Primary Purpose
Pre-Term
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Citicoline
Placebo oral tablet
Sponsored by
About this trial
This is an interventional treatment trial for Pre-Term
Eligibility Criteria
Inclusion Criteria:
- Preterm on CPAP or ventilator
Exclusion Criteria:
- Multiple congenital anomalies
Sites / Locations
- Sherief Abd-ElsalamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Citicoline
Placebo drug
Arm Description
Citicoline as neuroprotector
Placebo
Outcomes
Primary Outcome Measures
Number of children with affection of the brain
Number of children with affection of the brain
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03966170
Brief Title
Citicoline as Neuroprotector in Preterm
Official Title
Efficacy of Citicoline as Neuroprotector in Preterm; A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
November 2028 (Anticipated)
Study Completion Date
December 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherief Abd-Elsalam
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Citicoline as neuroprotector in preterm
Detailed Description
Efficacy of Citicoline as neuroprotector in preterm; A randomized controlled trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Term
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Citicoline
Arm Type
Experimental
Arm Description
Citicoline as neuroprotector
Arm Title
Placebo drug
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Citicoline
Intervention Description
Citicoline as neuroprotector
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
placebo drug
Primary Outcome Measure Information:
Title
Number of children with affection of the brain
Description
Number of children with affection of the brain
Time Frame
6 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Preterm on CPAP or ventilator
Exclusion Criteria:
Multiple congenital anomalies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam, ass. prof.
Phone
00201147773440
Email
sheriefabdelsalam@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
May R Elsheikh, MD
Organizational Affiliation
Tanta University - Faculty of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abeer Salamah, MD
Organizational Affiliation
Kafr-Elsheikh University - Faculty of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Sherief Abd-Elsalam
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Citicoline as Neuroprotector in Preterm
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