Role of Citicoline in Treatment of Neonates With Hypoxic Ischemic Encephalopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Citicoline Sodium.
- Who it may be relevant to
- Registry conditions: Hypoxic Ischemic Encephalopathy of Newborn. Basic parameters: 1 Day — 30 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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
Primary outcome measures
- survival in newborn babies with HIE [Time frame: one year after the start of study]
Eligibility criteria
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 -
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- MH — Rawalpindi
Identifiers
NCT: NCT06522581 · Citicoline for HIE