Table 3.
Unreported or ongoing clinical trial of pharmacotherapy for neonatal asphyxia.
| Drugs | Title | Interventions | Subjects | Phase | Country | Status | Number |
|---|---|---|---|---|---|---|---|
| Erythropoietin | Erythropoietin for Neonatal Encephalopathy in LMIC (EMBRACE Trial) | Erythropoietin monotherapy | Neonatal encephalopathy | Phase III | Bangladesh, India, Sri Lanka | Not yet recruiting | NCT05395195 |
| Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO) | 1,000/kg/dose × 5 doses | Cooled infants with HIE | Phase I/II | USA | Completed | NCT01913340 | |
| Neurological Outcome After Erythropoietin Treatment for Neonatal Encephalopathy | Either 300 U/kg or 500 U/kg, subcutaneously the first time and then intravenously every other day for 2 weeks. | HIE | Phase I/II | China | Completed | NCT00808704 | |
| Neonatal Erythropoietin in Asphyxiated Term Newborns (NEAT) | 250, 500, 1,000, or 2,500 U/kg/dose × 6 doses | Cooled infants with HIE | Phase I | USA | Completed | NCT00719407 | |
| Efficacy of Erythropoietin to Improve Survival and Neurological Outcome in Hypoxic Ischemic Encephalopathy (Neurepo) | 1,000 to 1,500 U/kg/dose, 3 dose every 24 h | Cooled infants with HIE | Phase III | France | Completed | NCT01732146 | |
| Neuroprotective Role of Erythropoietin in Perinatal Asphyxia | 500 units/kg/day every other day for 5 doses | Perinatal Asphyxia | Phase II/III | India | Completed | NCT02002039 | |
| Darbepoetin alfa | Darbepoetin in Neonatal Encephalopathy Trial (EDEN) | 10 μg/kg IV, 2 doses following cooling therapy. | Cooled infants with HIE | Phase II | UK | Recruiting | NCT04432662 |
| Mild Encephalopathy in the Newborn Treated With Darbepoetin (MEND) | 10 μg/kg/dose IV, one dose at <24 h of age | Mild HIE | Phase II | USA | Completed | NCT03071861 | |
| Darbe Administration in Newborns Undergoing Cooling for Encephalopathy (DANCE) | 2 or 10 μg/kg/dose IV, 2 dose, within 12 h and at 7 days old. | Cooled infants with HIE | Phase I/II | USA | Completed | NCT01471015 | |
| Epoetin alfa | Erythropoietin for Hypoxic Ischaemic Encephalopathy in Newborns (PAEAN) | 1,000 IU/kg, IV, on Days 1, 2, 3, 5 and 7 of age | Cooled infants with HIE | Phase III | Australia | Active, not recruiting | NCT03079167 |
| Melatonin | Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia | 0.5, 3, or 5 mg/kg enteral dose | Cooled infants with HIE | Early Phase 1 | USA | Recruiting | NCT02621944 |
| Use of Melatonin for Neuroprotection in Asphyxiated Newborns (MELPRO) | 10 mg/kg, 5 daily enteral doses | Cooled infants with HIE | Not Applicable | Italy | Recruiting | NCT03806816 | |
| Melatonin for Neuroprotection Following Perinatal Asphyxia | 10 mg/kg daily, 5 doses in total | Cooled infants with HIE | Phase I/II | Egypt | Completed | NCT02071160 | |
| Magnesium sulfate | Hypothermia Enhanced by Magnesium Sulphate (Hemen) | 250 mg/kg doses, 3 doses in total | Cooled infants with HIE | Phase II/III | Poland | Completed | NCT02499393 |
| Beneficial Effect of Intravenous Magnesium Sulphate in Term Neonates With Hypoxic Ischemic Encephalopathy (HIE) | 250 mg/kg/dose, 3 doses within postnatal 6 h, 24 h, and 48 h | HIE | Phase II | Pakistan | Completed | NCT04705142 | |
| Magnesium Sulphate in Perinatal Asphyxia (Magsulf) | 250 mg/kg, every 24 h starting at postnatal 6 h | Moderate to severe HIE | Phase III | India | Completed | NCT00553072 | |
| Xenon | Xenon and Cooling Therapy in Babies at High Risk of Brain Injury Following Poor Condition at Birth (CoolXenon2) | Xenon gas 50% for 18 h | Cooled infants with HIE | Phase I/II | UK | Completed | NCT01545271 |
| Xenon and Cooling Therapy in Babies at High Risk of Brain Injury Following Poor Condition at Birth (CoolXenon3) | Xenon gasv50% for 18 h | Cooled infants with HIE | Phase II | UK | Completed | NCT02071394 | |
| Stem cells | Neonatal Hypoxic Ischemic Encephalopathy: Safety and Feasibility Study of a Curative Treatment With Autologous Cord Blood Stem Cells | 5.107/kg injection of autologous mononuclear cells from umbilical cord blood | Cooled infants with HIE | Phase I/II | France | Recruiting | NCT02881970 |
| A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy for the Treatment of Traumatic Brain Injury and Hypoxic-Ischemic Encephalopathy | 3 infusions over 6 weeks at 14-day intervals | Traumatic brain injury | Phase I/II | USA | Active, not recruiting | NCT04063215 | |
| Study of hCT-MSC in Newborn Infants With Moderate or Severe HIE | Single dose within postnatal 48 h | Cooled infants with HIE | Phase I | USA | Completed | NCT03635450 | |
| Cord blood cells | Autologous Cord Blood Cells for Brain Injury in Term Newborns | Infant's own umbilical cord blood | HIE | Phase I | Singapore | Completed | NCT01649648 |
| Neuroprotective Effect of Autologous Cord Blood Combined With Therapeutic Hypothermia Following Neonatal Encephalopathy | Aliquots during postnatal 3 days | Cooled infants with HIE | Phase I/II | China | Recruiting | NCT02551003 |
HIE, hypoxic-ischemic encephalopathy; IV, intravenous; hCT-MSC, human umbilical cord tissue-derived mesenchymal stromal cells.