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Role of Citicoline in Treatment of Neonates With Hypoxic Ischemic Encephalopathy

NCT06522581 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-08-14

No results posted yet for this study

Summary

Hypoxic ischemic encephalopathy is an acute or subacute brain injury, due to asphyxia in neonates, leading to mortality and long-term morbidity. Its prevalence varies across regions, with developed countries reporting rates of 1.5 per 1000 live births, while developing nations experience a wider range from 2.3 to 26.5 per 1000 live births.

Infants afflicted with moderate HIE face a 10% risk of mortality, with surviving individuals encountering a 30% chance of developing disabilities. The prognosis is graver for severe HIE, with a mortality risk of 60%, and nearly all survivors experiencing some form of disability.

Conditions

  • Hypoxic Ischemic Encephalopathy of Newborn

Interventions

DRUG

Citicoline Sodium

one group of neonates with confirmed HIE grade II and III will receive injection citicoline through IV route within 06 hours of birth

Sponsors & Collaborators

  • Armed Forces Hospital, Pakistan

    lead OTHER

Principal Investigators

  • arshad Khushdil, FCPS · PEMH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2025-01-01
Completion
2025-01-01

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06522581 on ClinicalTrials.gov