Citicoline as Neuroprotector in Preterm

• Sponsor: Sherief Abd-Elsalam (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03966170
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 115.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Citicoline as neuroprotector in preterm

Condition or Disease	Intervention/Treatment	Phase
Pre-Term	Drug: Citicoline; Drug: Placebo oral tablet	Phase 3

Detailed Description

Efficacy of Citicoline as neuroprotector in preterm; A randomized controlled trial.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy of Citicoline as Neuroprotector in Preterm; A Randomized Controlled Trial
• Actual Study Start Date: May 1, 2019
• Anticipated Primary Completion Date: Nov 1, 2028
• Anticipated Study Completion Date: Dec 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Citicoline Citicoline as neuroprotector	Drug: Citicoline; Citicoline as neuroprotector
Placebo Comparator: Placebo drug Placebo	Drug: Placebo oral tablet; placebo drug

Outcome Measures

Primary Outcome Measures

1. Number of children with affection of the brain [6 months]

   Number of children with affection of the brain

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 1 Month
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Preterm on CPAP or ventilator

Exclusion Criteria:

• Multiple congenital anomalies

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sherief Abd-Elsalam	Tanta		Egypt

Sponsors and Collaborators

• Sherief Abd-Elsalam

Investigators

• Principal Investigator: May R Elsheikh, MD, Tanta University - Faculty of Medicine
• Study Director: Abeer Salamah, MD, Kafr-Elsheikh University - Faculty of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sherief Abd-Elsalam, Ass. Prof. Tropical Medicine, Tanta University
• ClinicalTrials.gov Identifier: NCT03966170
• Other Study ID Numbers: Citicoline
• First Posted: May 29, 2019
• Last Update Posted: May 29, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Premature Birth; Cytidine Diphosphate Choline

Study Results

No Results Posted as of May 29, 2019