22 completed, 8 recruiting, 4 not yet recruiting, 3 terminated. 42 Phase 2, 16 Phase 1, 3 Phase 3.
Follow Hypoxia, Brain: new trials by email Literature Review of Hypoxia, Brain trials Research Report on Hypoxia, Brain
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 |
|---|---|---|---|---|---|---|
| Intranasal Stem Cells to Treat Perinatal Brain Injury to Combat Cerebral Palsy MSC, marrow, Placebo - Perinatal Arterial Ischemic Stroke, Perinatal Asphyxia | Phase 2 / Phase 3 | Not yet recruiting | UMC Utrecht | 162 | 2027-04-01 | 2026-09-21 |
| The PROTECT-HIE Pilot Trial Dobutamine, TnECHO - Hypoxic-ischemic Encephalopathy (HIE) | Phase 2 | Recruiting | University of Alberta | 40 | 2026-10-13 | 2026-11-05 |
| Sildenafil Plus Hypothermia to Treat Neonatal Encephalopathy Sildenafil Citrate (IV) - Hypoxic-Ischemic Encephalopathy | Phase 2 | Not yet recruiting | Assistance Publique - Hôpitaux de Paris | 24 | 2026-10-01 | 2026-03-31 |
| Mesenchymal Stem Cells With Cooling Therapy for Infants With Hypoxic-Ischemic Encephalopathy Wharton's jelly-derived mesenchymal stem cells, 0.9 % Normal Saline - Hypoxic-Ischemic Encephalopathy, Neonatal, Brain Injuries, Hypoxic-Ischemic | Phase 1 / Phase 2 | Not yet recruiting | Mahidol University | 40 | 2026-09-15 | 2026-09-02 |
| EFFICACY OF MELATONIN IN MANAGEMENT OF HYPOXIC ISCHEMIC ENCEPHALOPATHY (HIE) IN NEONATES Melatonin, intravenous (IV) fluids, intensive monitoring, broad-spectrum antibiotic cover - Hypoxic Ischaemic Encephalopathy (HIE) | Phase 2 | Active not recruiting | University of Child Health Sciences and Children's Hospital, Lahore | 110 | 2025-12-10 | 2025-12-26 |
| Dexmedetomidine Versus Morphine During Cooling Therapy in Neonates Dexmedetomidine Infusion, Morphine Infusion - Hypoxic Ischemic Brain Injury, Neonatal Encephalopathy | Phase 2 | Not yet recruiting | Ipsita Goswami | 50 | 2025-07-01 | 2025-05-22 |
| Hypertonic Lactate After Cardiac Arrest Sodium Lactate Solution - Cardiac Arrest, Ischemia Reperfusion Injury | Phase 2 | Recruiting | Erasme University Hospital | 125 | 2025-02-19 | 2025-02-21 |
| Treatment of Neonatal Encephalopathy With Oral Sildenafil Suspension to Repair Brain Injury Secondary to Birth Asphyxia Sildenafil, Ora-Blend - Neonatal Encephalopathy | Phase 2 | Recruiting | Pia Wintermark | 60 | 2024-07-01 | 2026-09-17 |
| Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy Normal Saline along with standard treatment, Sovateltide along with standard treatment - Hypoxic-Ischemic Encephalopathy, Neonatal Asphyxia | Phase 2 | Recruiting | Pharmazz, Inc. | 40 | 2023-09-06 | 2025-12-31 |
| buRst-supprESsion TO Stop Refractory Status Epilepticus Post-cardiac Arrest Burst Suppression EEG Target Intravenous Anesthesia, Seizure Suppression EEG Target Intravenous Anesthesia - Hypoxia-Ischemia, Brain, Heart Arrest | Phase 2 | Recruiting | University of California, San Francisco | 30 | 2023-08-07 | 2026-07-29 |
| A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia RLS-0071, Placebo - Hypoxic-Ischemic Encephalopathy | Phase 2 / Phase 3 | Recruiting | ReAlta Life Sciences, Inc. | 173 | 2023-07-27 | 2026-11-05 |
| A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures Levetiracetam Injection, Phenobarbital Sodium Injection - Neonatal Seizure, Neonatal Encephalopathy | Phase 2 | Recruiting | University of California, San Diego | 133 | 2023-03-24 | 2026-10-15 |
| Cerebral Blood Flow and Ventilatory Responses During Sleep in Normoxia and Intermittent Hypoxia Drug Lowering Cerebral Blood Flow (CBF) and Normoxia Sleep, Drug Lowering CBF and Intermittent Hypoxia Sleep, Placebo and Normoxia Sleep - Obstructive Sleep Apnea of Adult, Hypoxia, Brain | Phase 1 / Phase 2 | Recruiting | University of Calgary | 12 | 2023-01-01 | 2026-05-01 |
| Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial) Dexmedetomidine Hydrochloride, Morphine Sulfate - Hypoxic-Ischemic Encephalopathy, Pain | Phase 2 | Completed | University of Utah | 50 | 2022-06-20 | 2026-03-06 |
| Brain Oxygenation-II Intervention for cerebral hypoxia - Cerebral Hypoxia | Phase 2 | Unknown | Valerie Chock, M.D., M.S. Epi | 100 | 2022-04-07 | 2024-04-18 |
| Multiple N-of-1 Trials of (Intermittent) Hypoxia Therapy in Parkinson's Disease Hypoxic Gas Mixture - Parkinson Disease, Effect of Drug | Phase 1 / Phase 2 | Completed | Radboud University Medical Center | 29 | 2022-02-22 | 2023-07-21 |
| 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 HB-adMSCs - Traumatic Brain Injury | Phase 1 / Phase 2 | Completed | Hope Biosciences LLC | 24 | 2020-01-01 | 2026-11-09 |
| Autologous Cord Blood and Human Placental Derived Stem Cells in Neonates With Severe Hypoxic-Ischemic Encephalopathy HPDSC, Cord blood - Severe Hypoxic-ischemic Encephalopathy | Phase 2 | Withdrawn | New York Medical College | 2019-12-01 | 2021-02-23 | |
| A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies TAK-935, Placebo - Epilepsy, Dravet Syndrome | Phase 2 | Completed | Takeda | 141 | 2018-08-08 | 2026-09-14 |
| Levetiracetam Treatment of Neonatal Seizures: Safety and Efficacy Phase II Study Intravenous Levetiracetam - Neonatal Seizures | Phase 2 | Completed | University Hospital, Tours | 18 | 2018-02-27 | 2025-12-30 |
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Hypoxia-Ischemia, Brain (37) · Asphyxia Neonatorum (6) · Hypothermia (4) · Asphyxia (3) · Brain Injuries (3) · Brain Injuries, Traumatic (3) · Heart Arrest (3) · Seizures (3) · Cerebral Palsy (2) · Hypoxia (2) · Lymphoma, Follicular (2) · Stroke (2) · Agnosia (1) · Autonomic Nervous System Diseases (1)
Pathological Conditions, Signs and Symptoms (42) · Signs and Symptoms (42) · Signs and Symptoms, Respiratory (42) · Brain Diseases (41) · Central Nervous System Diseases (41) · Nervous System Diseases (41) · Hypoxia (40) · Cardiovascular Diseases (38) · Cerebrovascular Disorders (38) · Vascular Diseases (38) · Brain Ischemia (37) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (8) · Neurologic Manifestations (7) · Wounds and Injuries (7)
Hypothermia, Induced (3) · Lasers, Gas (2) · Saline Solution (2) · Sildenafil Citrate (2) · Topiramate (2) · 2-iminobiotin (1) · Baclofen (1) · Bumetanide (1) · Cerebrovascular Circulation (1) · Clonidine (1) · Cool-Down Exercise (1) · Core Binding Factors (1) · Darbepoetin alfa (1) · Dexmedetomidine (1) · Dobutamine (1)
University Hospitals Bristol and Weston NHS Foundation Trust (2) · University of California, San Francisco (2) · University of Utah (2) · Zhengzhou University (2) · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (1) · Assistance Publique - Hôpitaux de Paris (1) · Children's Hospital of Fudan University (1) · Erasme University Hospital (1) · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (1) · Great Ormond Street Hospital for Children NHS Foundation Trust (1) · Hope Biosciences LLC (1) · Ipsita Goswami (1) · Johns Hopkins University (1) · Kristin R Hoffman (1) · Loewenstein Hospital (1)
United States (15) · Canada (5) · China (4) · France (3) · Netherlands (3) · United Kingdom (3) · Egypt (2) · India (2) · Israel (2) · Australia (1) · Belgium (1) · Hungary (1) · Ireland (1) · Italy (1) · New Zealand (1)
Changlian Zhu, MD, PhD (2) · Mariana Baserga, MD (2) · Marianne Thoresen, Professor (2) · Anil Gulati (1) · Balraj Guhan, MD (1) · Charles S Cox, MD (1) · Cynthia M Sharpe, M.D. (1) · Dorothea D Jenkins, MD (1) · Edilberto Amorim, MD (1) · Emmanuel Cuny, Professor (1) · Estelle B Gauda, MD (1) · Filippo Annoni, MD (1) · Geraldine Favrais, Dr (1) · Ipsita Goswami, MD (1)
PMID 24524452, PMID 15199405, PMID 15607598, PMID 15607599, PMID 19172693, PMID 19883750, PMID 20385632, PMID 20631189, PMID 22805873, PMID 22950861, PMID 23133515, PMID 23897243, PMID 24473179, PMID 25765333, PMID 25794112, PMID 27126393, PMID 27535166, PMID 27614933, PMID 27632779, PMID 28949952, PMID 29016557, PMID 29769612, PMID 30661082, PMID 30679288, PMID 31155392, PMID 31261373, PMID 32813884, PMID 33362471, PMID 34482377, PMID 34764335, PMID 35836147, PMID 35841234, PMID 35995129, PMID 37422495, PMID 38902120, PMID 39498807, PMID 40983658
2014 (1), 2017 (1), 2018 (1), 2023 (1), 2025 (1), R01HD038600 (1), R01NS038062 (1)