Hypoxic Ischemic Encephalopathy Clinical Trial
Official title:
Darbe Administration in Newborns Undergoing Cooling for Encephalopathy
Selective head cooling or whole body hypothermia has become the standard of care for
neonatal hypoxia-ischemia encephalopathy (HIE). Despite early intervention death or major
neurodevelopmental disability still occurs in nearly 50% of infants ≥ 36 weeks gestational
age (GA) treated with cooling. No additional therapies have proven to be efficacious in
further reducing brain injury and impairment for these high risk infants. Neuroprotective
strategies aimed at improving early childhood outcomes are still needed. An important area
of study includes therapies that may complement the neuroprotective effects of hypothermia
and promote neuronal regeneration, recovery and neurovascular remodeling. Among these
therapies, erythropoiesis stimulating agents (ESA) have been shown to provide
neuroprotection, improving short and long-term neurologic outcome in brain injury and HIE in
neonatal and adult animal models. Parallel with neuroprotective effects in experimental
settings, recent small clinical studies suggest improved outcomes after ESA administration
in patients with severe traumatic brain injury and HIE. ESA may work through several
important mechanisms including reduced inflammation, limited oxidative stress, decreased
apoptosis and white matter injury, as well as via pro-angiogenic and neurogenic properties.
Darbepoetin alfa (Darbe), a recombinant human erythropoietin (EPO)-derived molecule, has an
extended circulating half life and comparable biological activity to EPO, including
activation of the EPO receptor. The proposed study is a Phase I/II dose safety and
pharmacokinetic trial of early Darbe administered concurrent with hypothermia in human
newborn infants with moderate to severe birth asphyxia. The long-term objectives of the
proposed research are to reduce mortality and to decrease the risk of long-term disabilities
in infants with HIE who survive beyond the newborn period.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT02551003 -
Neuroprotective Effect of Autologous Cord Blood Combined With Therapeutic Hypothermia Following Neonatal Encephalopathy
|
Phase 1/Phase 2 | |
Completed |
NCT02683915 -
Reno-protective Effect of Brain Cooling in Newborn With Hypoxia
|
||
Recruiting |
NCT01962233 -
Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Hypoxic Ischemic Encephalopathy
|
Phase 1 | |
Completed |
NCT01683383 -
California Transport Cooling Trial
|
N/A | |
Completed |
NCT01481207 -
Magnetic Resonance Imaging and Spectroscopy Biomarkers of Neonatal Hypoxic Ischemic Encephalopathy
|
||
Completed |
NCT01649648 -
Autologous Cord Blood Cells for Brain Injury in Term Newborns
|
Phase 1 | |
Withdrawn |
NCT00993564 -
Magnetic Resonance Imaging (MRI) Thermal Imaging of Infants Undergoing Cooling for Hypoxic Ischemic Encephalopathy (HIE)
|
N/A | |
Completed |
NCT00945789 -
Erythropoietin in Infants With Hypoxic Ischemic Encephalopathy (HIE)
|
Phase 1/Phase 2 | |
Completed |
NCT00097097 -
Neonatal Resuscitation in Zambia
|
Phase 3 | |
Recruiting |
NCT02621944 -
Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia
|
Early Phase 1 | |
Not yet recruiting |
NCT02605018 -
Neuroprotective Effect of Autologous Cord Blood Combined With Therapeutic Hypothermia Following Neonatal Encephalopathy
|
Phase 1/Phase 2 | |
Withdrawn |
NCT01128673 -
MRI Thermal Imaging of Infants Undergoing Cooling for Hypoxic Ischemic Encephalopathy(HIE)
|
N/A | |
Completed |
NCT01732146 -
Efficacy of Erythropoietin to Improve Survival and Neurological Outcome in Hypoxic Ischemic Encephalopathy
|
Phase 3 | |
Completed |
NCT02349672 -
Clinical Utility of Serum Biomarkers for the Management of Neonatal Hypoxic Ischemic Encephalopathy (Control Levels)
|
||
Completed |
NCT02826941 -
Moderate Hypothermia in Neonatal Hypoxic Ischemic Encephalopathy
|
Phase 2 | |
Active, not recruiting |
NCT01138176 -
Whole Body Cooling Using Phase Changing Material
|
Phase 1/Phase 2 | |
Recruiting |
NCT02578823 -
Targeted Temperature Management After In-Hospital Cardiac Arrest
|
N/A | |
Terminated |
NCT01765218 -
Topiramate in Neonates Receiving Whole Body Cooling for Hypoxic Ischemic Encephalopathy
|
Phase 1/Phase 2 | |
Completed |
NCT01241019 -
Safety and Efficacy of Topiramate in Neonates With Hypoxic Ischemic Encephalopathy Treated With Hypothermia
|
Phase 2 | |
Completed |
NCT00620711 -
Pilot Study of Head Cooling in Preterm Infants With Hypoxic Ischemic Encephalopathy
|
Phase 1 |