Back to resultsCiticoline as Neuroprotector in Neonates Exposed to Hypoxia
Primary Purpose
Neonatal Hypoxia
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Citicoline
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Neonatal Hypoxia
Eligibility Criteria
Inclusion Criteria:
- neonates with hypoxia.
Exclusion Criteria:
- hypoxic ischemic encephalopathy
Sites / Locations
- Sherief Abd-ElsalamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Citacoline
Placebo
Arm Description
Citacoline as neuroprotector
Placebo
Outcomes
Primary Outcome Measures
number of seizures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03949049
Brief Title
Citicoline as Neuroprotector in Neonates Exposed to Hypoxia
Official Title
Efficacy of Citicoline as Neuroprotector in Neonates Exposed to Hypoxia: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
December 1, 2029 (Anticipated)
Study Completion Date
December 1, 2029 (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
No
5. Study Description
Brief Summary
Citicoline as neuroprotector in neonates exposed to hypoxia: A randomized controlled trial
Detailed Description
Efficacy of Citicoline as neuroprotector in neonates exposed to hypoxia: A randomized controlled trial
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Hypoxia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Citacoline
Arm Type
Experimental
Arm Description
Citacoline as neuroprotector
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Citicoline
Other Intervention Name(s)
citacoline
Intervention Description
Citacoline as neuroprotector
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
placebo group
Primary Outcome Measure Information:
Title
number of seizures
Time Frame
6 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
neonates with hypoxia.
Exclusion Criteria:
hypoxic ischemic encephalopathy
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
Abeer Salamah, Lecturer
Organizational Affiliation
Pediatrics department - Kafr-Elsheikh university
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
May R Elsheikh, Lecturer
Organizational Affiliation
Pediatrics department - Tanta university
Official's Role
Study Chair
Facility Information:
Facility Name
Sherief Abd-Elsalam
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherief Abd-elsalam, lecturer
Phone
00201000040794
Email
Sherif_tropical@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Citicoline as Neuroprotector in Neonates Exposed to Hypoxia
We'll reach out to this number within 24 hrs