Role of Citicoline in Treatment of Neonates With Hypoxic Ischemic Encephalopathy

Phase 1

Recruiting

• Conditions: Hypoxic Ischemic Encephalopathy of Newborn
• Interventions: Drug: Citicoline Sodium

• Registration Number: NCT06522581
• Lead Sponsor: Armed Forces Hospital, Pakistan

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-22
• Study First Posted: 2024-07-26
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-14
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. all indoor newborn babies with HIE II and III
2. who have not received therapeutic hypothermia

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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 -

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
neonates with HIE receiving citicoline	Citicoline Sodium	this arm will include neonates suffering from hypoxic ischemic encephalopathy and who will be given injection citicoline
neonates with HIE receiving placebo	Citicoline Sodium	this arm will include neonates who will be suffering from HIE but will recieve rotuine care in NICU but will not receive injection citicoline

Primary Outcome Measures

Name	Time	Method
survival in newborn babies with HIE	one year after the start of study	we will be evaluationg the efficacy of citicoline in newborns with HIE

Trial Locations

Locations (1)

MH; 🇵🇰 Rawalpindi, Pakistan