Citicoline as Neuroprotector in Neonates Exposed to Hypoxia

NCT ID: NCT03949049

Last Updated: 2019-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2029-12-01

Brief Summary

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

Detailed Description

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

Conditions

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Neonatal Hypoxia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Citacoline

Citacoline as neuroprotector

Group Type EXPERIMENTAL

Citicoline

Intervention Type DRUG

Citacoline as neuroprotector

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

placebo group

Interventions

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Citicoline

Citacoline as neuroprotector

Intervention Type DRUG

Placebo

placebo group

Intervention Type OTHER

Other Intervention Names

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citacoline

Eligibility Criteria

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Inclusion Criteria

* neonates with hypoxia.

Exclusion Criteria

* hypoxic ischemic encephalopathy
Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sherief Abd-Elsalam

OTHER

Sponsor Role lead

Responsible Party

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Sherief Abd-Elsalam

Ass Prof Tanta University

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Abeer Salamah, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Pediatrics department - Kafr-Elsheikh university

May R Elsheikh, Lecturer

Role: STUDY_CHAIR

Pediatrics department - Tanta university

Locations

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Sherief Abd-Elsalam

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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sherief abd-elsalam, ass. prof.

Role: CONTACT

00201147773440

Facility Contacts

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Sherief Abd-elsalam, lecturer

Role: primary

00201000040794

References

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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.

Reference Type DERIVED
PMID: 37173784 (View on PubMed)

Other Identifiers

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neonates tanta

Identifier Type: -

Identifier Source: org_study_id

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