NCT03966170

Brief Summary

Citicoline as neuroprotector in preterm

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
32mo left

Started May 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 Progress73%
May 2019Dec 2028

Study Start

First participant enrolled

May 1, 2019

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 24, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 29, 2019

Completed
9.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

May 29, 2019

Status Verified

May 1, 2019

Enrollment Period

9.5 years

First QC Date

May 24, 2019

Last Update Submit

May 24, 2019

Conditions

Pre-Term

Outcome Measures

Primary Outcomes (1)

  • Number of children with affection of the brain

    Number of children with affection of the brain

    6 months

Study Arms (2)

Citicoline

EXPERIMENTAL

Citicoline as neuroprotector

Drug: Citicoline

Placebo drug

PLACEBO COMPARATOR

Placebo

Drug: Placebo oral tablet

Interventions

CiticolineDRUG

Citicoline as neuroprotector

Citicoline
Placebo oral tabletDRUG

placebo drug

Placebo drug

Eligibility Criteria

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

You may qualify if:

  • Preterm on CPAP or ventilator

You may not qualify if:

  • Multiple congenital anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherief Abd-Elsalam

Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

Premature Birth

Interventions

Cytidine Diphosphate Choline

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • May R Elsheikh, MD

    Tanta University - Faculty of Medicine

    PRINCIPAL INVESTIGATOR

  • Abeer Salamah, MD

    Kafr-Elsheikh University - Faculty of Medicine

    STUDY DIRECTOR

Central Study Contacts

Sherief Abd-Elsalam, ass. prof.

CONTACT

00201147773440sheriefabdelsalam@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ass. Prof. Tropical Medicine

Study Record Dates

First Submitted

May 24, 2019

First Posted

May 29, 2019

Study Start

May 1, 2019

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

May 29, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)