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NCT Number: NCT06522581

Role of Citicoline in Treatment of Neonates With Hypoxic Ischemic Encephalopathy

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.

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Key information

Conditions

Hypoxic Ischemic Encephalopathy of Newborn

Age range

1 day–30 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all indoor newborn babies with HIE II and III
  • who have not received therapeutic hypothermia

Exclusion criteria

  • grade I HIE
  • Babies on TH
  • babies whose parents do not give consent for inclusion in study
  • babies with major congential malformations -

Treatment and study plan

Citicoline Sodium

Drug

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

Other names: placebo

Primary outcomes

  1. survival in newborn babies with HIE

    Time frame: one year after the start of study

    we will be evaluationg the efficacy of citicoline in newborns with HIE

Study contacts

Contact information is provided by the study sponsor or research team.

arshad Khushdil

CONTACT

[email protected]

03463300030

arshad Khushdil

CONTACT

03463300030

Sponsors and collaborators

Lead sponsor

Armed Forces Hospital, Pakistan

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 26, 2024
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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