Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01471015
Study type Interventional
Source University of Utah
Contact
Status Completed
Phase Phase 1/Phase 2
Start date September 2012
Completion date January 2014

See also
  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Withdrawn NCT02551003 - Neuroprotective Effect of Autologous Cord Blood Combined With Therapeutic Hypothermia Following Neonatal Encephalopathy Phase 1/Phase 2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 NCT01649648 - Autologous Cord Blood Cells for Brain Injury in Term Newborns Phase 1
Completed NCT01481207 - Magnetic Resonance Imaging and Spectroscopy Biomarkers of Neonatal Hypoxic Ischemic Encephalopathy
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