Role of Citicoline in Treatment of Neonates With Hypoxic Ischemic Encephalopathy

NCT ID: NCT06522581

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-01-01

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.

Conditions

Hypoxic Ischemic Encephalopathy of Newborn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

neonates with HIE receiving citicoline

this arm will include neonates suffering from hypoxic ischemic encephalopathy and who will be given injection citicoline

Group Type: EXPERIMENTAL

Citicoline Sodium

Intervention Type: DRUG

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

neonates with HIE receiving placebo

this arm will include neonates who will be suffering from HIE but will recieve rotuine care in NICU but will not receive injection citicoline

Group Type: PLACEBO_COMPARATOR

Citicoline Sodium

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

placebo

Eligibility Criteria

Inclusion Criteria

1. all indoor newborn babies with HIE II and III

2. who have not received therapeutic hypothermia

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 -

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 30 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Armed Forces Hospital, Pakistan

OTHER

Sponsor Role: lead

Responsible Party

arshad khushdil

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

arshad Khushdil, FCPS

Role: PRINCIPAL_INVESTIGATOR

PEMH

Locations

MH

Rawalpindi, , Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

arshad Khushdil

Role: CONTACT

drarshad104589@yahoo.com

03463300030

arshad Khushdil

Role: CONTACT

03463300030

Facility Contacts

arshad Khushdil

Role: primary

drarshad104589@yahoo.com

03463300030

Other Identifiers

Citicoline for HIE

Identifier Type: -

Identifier Source: org_study_id