NCT03949049

Brief Summary

Citicoline as neuroprotector in neonates exposed to hypoxia: A randomized controlled trial

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
44mo left

Started Feb 2019

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Feb 2019Dec 2029

Study Start

First participant enrolled

February 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 14, 2019

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

May 29, 2019

Status Verified

May 1, 2019

Enrollment Period

10.8 years

First QC Date

May 11, 2019

Last Update Submit

May 24, 2019

Conditions

Neonatal Hypoxia

Outcome Measures

Primary Outcomes (1)

  • number of seizures

    6 months

Study Arms (2)

Citacoline

EXPERIMENTAL

Citacoline as neuroprotector

Drug: Citicoline

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

CiticolineDRUG

Citacoline as neuroprotector

Also known as: citacoline
Citacoline
PlaceboOTHER

placebo group

Placebo

Eligibility Criteria

AgeUp to 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • neonates with hypoxia.

You may not qualify if:

  • hypoxic ischemic encephalopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherief Abd-Elsalam

Cairo, Egypt

RECRUITING

Related Publications (1)

  • Salamah A, El Amrousy D, Elsheikh M, Mehrez M. Citicoline in hypoxic ischemic encephalopathy in neonates: a randomized controlled trial. Ital J Pediatr. 2023 May 12;49(1):55. doi: 10.1186/s13052-023-01452-5.

    PMID: 37173784DERIVED

MeSH Terms

Conditions

Asphyxia Neonatorum

Interventions

Cytidine Diphosphate Choline

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

CholineTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsOnium CompoundsCytidine DiphosphateCytosine NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • Abeer Salamah, Lecturer

    Pediatrics department - Kafr-Elsheikh university

    PRINCIPAL INVESTIGATOR

  • May R Elsheikh, Lecturer

    Pediatrics department - Tanta university

    STUDY CHAIR

Central Study Contacts

sherief abd-elsalam, ass. prof.

CONTACT

00201147773440sheriefabdelsalam@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ass Prof Tanta University

Study Record Dates

First Submitted

May 11, 2019

First Posted

May 14, 2019

Study Start

February 1, 2019

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

May 29, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)