6 completed, 1 active not recruiting, 1 enrolling by invitation, 1 not yet recruiting. 11 Phase 1, 3 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 11 | Completed 6, Active not recruiting 1, Enrolling by invitation 1, Not yet recruiting 1, Unknown 1, Withdrawn 1 |
| Phase 2 | 3 | Completed 3 |
Follow Hypoxic-Ischemic Encephalopathy: new trials by email Literature Review of Hypoxic-Ischemic Encephalopathy trials Research Report on Hypoxic-Ischemic Encephalopathy
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Hydrogen In Neonatal Encephalopathy (HIE) Trial Hydrogen Gas (H2) - HIE, Hypoxic-Ischemic Encephalopathy | Phase 1 | Not yet recruiting | Boston Children's Hospital | 54 | 2026-03-01 | 2026-02-17 |
| A Safety and Feasibility Trial Protocol of Metformin in Infants After Perinatal Brain Injury Metformin - Hypoxic-Ischemic Encephalopathy, HIE | Phase 1 | Enrolling by invitation | Boston Children's Hospital | 30 | 2025-10-01 | 2026-02-17 |
| Dose Optimization of Caffeine for HIE Caffeine citrate 20 mg/kg, Caffeine citrate 30 mg/kg - Hypoxic-Ischemic Encephalopathy | Phase 1 | Active not recruiting | University of North Carolina, Chapel Hill | 16 | 2024-07-26 | 2026-08-14 |
| PK and Safety of Caffeine in Neonates With Hypoxic Ischemic Encephalopathy Receiving Therapeutic Hypothermia Caffeine citrate - Acute Kidney Injury, Hypoxic-Ischemic Encephalopathy | Phase 1 | Withdrawn | University of Arkansas | 2024-05-08 | 2024-05-10 | |
| Caffeine for Hypoxic-Ischemic Encephalopathy Caffeine Citrate 5 mg/kg, Caffeine Citrate 10 mg/kg - Hypoxic-Ischemic Encephalopathy | Phase 1 | Completed | University of North Carolina, Chapel Hill | 17 | 2019-08-14 | 2025-03-27 |
| Feasibility and Safety of Umbilical Cord Blood Transfusion in the Treatment of Neonatal Cerebral Ischemia and Anemia autologous umbilical cord blood (UCB), standard care - Hypoxic-Ischemic Encephalopathy, Hypoxia Neonatal | Phase 1 | Unknown | Mononuclear Therapeutics Ltd. | 40 | 2018-04-16 | 2018-06-07 |
| Autologous Cord Blood Cell Therapy for Neonatal Encephalopathy Autologous umbilical cord blood cells - Neonatal Encephalopathy, Hypoxic-ischemic Encephalopathy | Phase 1 | Completed | Neonatal Encephalopathy Consortium, Japan | 6 | 2014-08-01 | 2019-10-29 |
| Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO) Erythropoietin, Normal saline - Hypoxic-ischemic Encephalopathy, Neonatal Encephalopathy | Phase 1 / Phase 2 | Completed | University of California, San Francisco | 50 | 2013-09-01 | 2020-07-13 |
| Neonatal Erythropoietin in Asphyxiated Term Newborns erythropoietin - Hypoxic-ischemic Encephalopathy | Phase 1 | Completed | University of California, San Francisco | 24 | 2010-01-01 | 2012-11-09 |
| Neurological Outcome After Erythropoietin Treatment for Neonatal Encephalopathy recombinant human erythropoietin - Hypoxic-Ischemic Encephalopathy | Phase 1 / Phase 2 | Completed | Zhengzhou University | 167 | 2003-08-01 | 2008-12-16 |
| Systemic Hypothermia Improves Outcome of Hypoxic-Ischemic Encephalopathy hypothermia - Hypoxic-Ischemic Encephalopathy | Phase 1 / Phase 2 | Completed | Zhengzhou University | 100 | 2002-07-01 | 2009-01-06 |
Hypoxia-Ischemia, Brain (11) · Asphyxia Neonatorum (3) · Asphyxia (2) · Brain Injuries (2) · Acute Kidney Injury (1) · Anemia, Neonatal (1) · Hypothermia (1)
Brain Diseases (11) · Brain Ischemia (11) · Cardiovascular Diseases (11) · Central Nervous System Diseases (11) · Cerebrovascular Disorders (11) · Hypoxia (11) · Hypoxia, Brain (11) · Nervous System Diseases (11) · Pathological Conditions, Signs and Symptoms (11) · Signs and Symptoms (11) · Signs and Symptoms, Respiratory (11) · Vascular Diseases (11) · Wounds and Injuries (4) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (3) · Infant, Newborn, Diseases (3)
caffeine citrate (3) · Epoetin Alfa (2) · Erythropoietin (2) · Metformin (1) · Saline Solution (1) · Standard of Care (1)
Boston Children's Hospital (2) · University of California, San Francisco (2) · University of North Carolina, Chapel Hill (2) · Zhengzhou University (2) · Mononuclear Therapeutics Ltd. (1) · Neonatal Encephalopathy Consortium, Japan (1) · University of Arkansas (1)
United States (6) · China (2) · Hong Kong (1) · Japan (1)
Brian Kalish, MD (2) · Changlian Zhu, MD, PhD (2) · Wesley M Jackson, MD, MPH (2) · Yvonne W Wu, MD, MPH (2) · Haruo Shintaku, MD, PhD (1) · Jennifer Rumpel, MD (1) · Simon Lam, MD (1)
PMID 23008465, PMID 24524452, PMID 25439577, PMID 30661082, PMID 31261373, PMID 37587184, PMID 40850908
K23HD111623 (1)