Role of Citicoline in Treatment of Neonates With Hypoxic Ischemic Encephalopathy

Last updated: August 12, 2024
Sponsor: Armed Forces Hospital, Pakistan
Overall Status: Active - Recruiting

Phase

1

Condition

Occlusions

Cerebral Ischemia

Neurologic Disorders

Treatment

Citicoline Sodium

Clinical Study ID

NCT06522581
Citicoline for HIE
  • Ages 1-30
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. all indoor newborn babies with HIE II and III

  2. who have not received therapeutic hypothermia

Exclusion

Exclusion Criteria:

  1. grade I HIE

  2. Babies on TH

  3. babies whose parents do not give consent for inclusion in study

  4. babies with major congential malformations -

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Citicoline Sodium
Phase: 1
Study Start date:
January 01, 2024
Estimated Completion Date:
January 01, 2025

Study Description

A number of treatment modalities are available but are not clinically effective due to inefficacy and undesirable side effects. Despite therapeutic hypothermia being the sole effective neuroprotector to date, its applicability is limited in certain scenarios, such as gestational age below 36 weeks, birth weight under 2000 g, and initiation beyond 6 hours of age. Therefore, there is a critical need to explore alternative, safe, effective, and accessible neuroprotective therapies, particularly in developing nations.

Citicoline, cytidine 5-diphosphocholine, is an exogenous substance and a product of rate limiting step of phosphatidyl choline synthesis. It has rapid absorption through enteral route where it breaks into cytidine and choline. Citicoline is a favorable recently developed neuroprotector in HIE as it helps to regenerate neuronal cells by inhibiting different steps of ischemic cascade like inhibiting glutamate built up and ROS synthesis increasing dopamine and acetylcholine neurotransmitters, regenerating injured cell membrane and increasing brain plasticity and repair.

In this study, effects of citicoline as a neuroprotector are evaluated in neonates with moderate and severe HIE.

Connect with a study center

  • MH

    Rawalpindi, 68000
    Pakistan

    Active - Recruiting

  • PEMH

    Rawalpindi, 68000
    Pakistan

    Active - Recruiting

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