Hypoxic-Ischemic Encephalopathy Clinical Trial
Official title:
Role of Citicoline in Treatment of Newborns With Hypoxic Ischemic Encephalopathy
Citicoline, is a naturally occurring compound and an intermediate in the metabolism of
phosphatidylcholine. Phosphatidylcholine is an important component of the phospholipids of
the cell membranes. Citicoline is composed of two molecules: cyti¬dine and choline. Both
these molecules enter the brain separately and by passing through the blood-brain barrier
where they act as substrates for intracellular synthesis of CDP-choline . This drug has been
widely used in adults who suffer from acute ischemic strokes for than 4 decades with good
results and has been proved to have a very good safety profile as well. It has various
therapeutic effects at several stages of the ischemic cascade in acute ischemic stroke.
1. It stabilizes cell membranes by increasing phosphatidylcholine and sphingomyelin
synthesis and by inhibiting the release of free fatty acids . By protecting membranes,
citicoline inhibits glutamate release during ischemia. In an experimental model of
ischemia in the rat, citicoline treatment decreased glutamate levels and stroke size.
2. Citicoline favors the synthesis of nucleic acids, proteins, acetylcholine and other
neurotransmitters, and decreases free radical formation Therefore, citicoline
simultaneously inhibits different steps of the ischemic cascade protecting the injured
tissue against early and delayed mechanisms responsible for ischemic brain injury.
3. citicoline may facilitate recovery by enhancing synaptic outgrowth and increased
neuroplasticity with decrease of neurologic deficits and improvement of behavioral
performance.
Considering these pharmacologic properties of citicoline, we are planning to see its effects
in newborns who have HIE which causes a global acute ischemic changes in developing brain.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05048550 -
Babies in Glasses; a Feasibility Study.
|
N/A | |
| Recruiting |
NCT05514340 -
Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy
|
Phase 2 | |
| Recruiting |
NCT05836610 -
Hydrocortisone Therapy Optimization During Hypothermia Treatment in Asphyxiated Neonates
|
Phase 4 | |
| Completed |
NCT03024021 -
Cerebral Oxymetry and Neurological Outcome in Therapeutic Hypothermia
|
||
| Completed |
NCT01913340 -
Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO)
|
Phase 1/Phase 2 | |
| Enrolling by invitation |
NCT02260271 -
Florida Neonatal Neurologic Network
|
||
| Terminated |
NCT01192776 -
Optimizing (Longer, Deeper) Cooling for Neonatal Hypoxic-Ischemic Encephalopathy(HIE)
|
N/A | |
| Completed |
NCT06344286 -
The Effects of Minimal Enteral Nutrition on Mesenteric Blood Flow and Oxygenation in Neonates With HIE
|
N/A | |
| Recruiting |
NCT05901688 -
Umbilical Cord Abnormalities in the Prediction of Adverse Pregnancy Outcomes
|
||
| Recruiting |
NCT02894866 -
Hyperbaric Oxygen Therapy Improves Outcome of Hypoxic-Ischemic Encephalopathy
|
N/A | |
| Recruiting |
NCT03657394 -
Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries
|
N/A | |
| Recruiting |
NCT03682042 -
Comparative Outcomes Related to Delivery-room Cord Milking In Low-resourced Kountries Developmental Follow Up
|
N/A | |
| Withdrawn |
NCT03681314 -
Umbilical Cord Milking in Neonates Who Are Depressed at Birth-Developmental Follow Up (MIDAB-FU)
|
N/A | |
| Completed |
NCT03485781 -
Propofol-induced EEG Changes in Hypoxic Brain Injury
|
||
| Recruiting |
NCT05568264 -
Effects of a Physical Therapy Intervention on Motor Delay in Infants Admitted to a Neonatal Intensive Care Unit
|
N/A | |
| Completed |
NCT02264808 -
Developmental Outcomes
|
||
| Completed |
NCT05687708 -
Effect of Non-nutritive Sucking on Transition to Oral Feeding in Infants With Asphyxia
|
N/A | |
| Recruiting |
NCT06195345 -
Individual Cerebral Hemodynamic Oxygenation Relationships (ICHOR 1)
|
||
| Completed |
NCT01793129 -
Preemie Hypothermia for Neonatal Encephalopathy
|
N/A | |
| Completed |
NCT00890409 -
Safety and Efficacy of Hypothermia to Treat Neonatal Hypoxic-Ischemic Encephalopathy
|
Phase 3 |