6 completed, 2 terminated, 1 unknown. 9 Phase 2, 3 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 9 | Completed 6, Terminated 2, Unknown 1 |
| Phase 1 | 3 | Completed 2, Unknown 1 |
| Phase 3 | 1 | Terminated 1 |
Follow Encephalomalacia: new trials by email Literature Review of Encephalomalacia trials Research Report on Encephalomalacia
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 |
|---|---|---|---|---|---|---|
| A Study to Investigate the Safety and Efficacy of UC-MSCs in Pediatric Patients With Cerebral Palsy UDI-001 - Cerebral Palsy, Periventricular Leukomalacia | Phase 1 / Phase 2 | Completed | Rohto Pharmaceutical Co., Ltd. | 6 | 2021-06-02 | 2025-04-06 |
| Antibiotic "Dysbiosis" in Preterm Infants Antibiotic, Gastric fluid, Breast milk - Enterocolitis, Necrotizing, Bacteremia | Phase 2 | Completed | University of Florida | 98 | 2017-01-16 | 2024-06-05 |
| Effects of Delayed Cord Clamp and/or Indomethacin on Preterm Infant Brain Injury Indomethacin, delay in umbilical cord clamp at birth, placebo infusion - Intraventricular Hemorrhage, Periventricular Leukomalacia | Phase 1 / Phase 2 | Completed | Hong Huang | 256 | 2014-08-01 | 2021-11-23 |
| Randomized Trial of Maternal Progesterone Therapy Progesterone, Vaginal lubricant - Congenital Heart Disease, Periventricular Leucomalacia | Phase 2 | Completed | Children's Hospital of Philadelphia | 102 | 2014-07-01 | 2023-08-09 |
| Recombinant Erythropoietin for Neuroprotection in Very Preterm Infants recombinant human erythropoietin (rhEpo), Normal saline - Infant, Premature, Leukomalacia, Periventricular | Phase 1 / Phase 2 | Unknown | China Medical University Hospital | 100 | 2009-08-01 | 2009-05-29 |
| Inhaled Nitric Oxide and Neuroprotection in Premature Infants inhaled nitric oxide, oxygen - Prematurity, Bronchopulmonary Dysplasia | Phase 2 / Phase 3 | Terminated | University of Chicago | 273 | 2008-05-01 | 2024-10-17 |
| High-Dose Erythropoietin in Extremely Premature Infants to Prevent/Attenuate Brain Injury: A Phase II Study Erythropoietin, Saline placebo - Infant, Premature, Erythropoietin | Phase 2 | Terminated | Atlantic Health System | 22 | 2007-07-01 | 2013-07-30 |
| Does Erythropoietin Improve Outcome in Very Preterm Infants? Recombinant human Erythropoietin, saline - Intracranial Hemorrhage, Periventricular Leukomalacia | Phase 2 | Completed | Swiss Neonatal Network | 420 | 2006-01-01 | 2018-10-30 |
| Randomized Trial of Hydrocortisone in Very Preterm High-Risk Infants Hydrocortisone, Placebo - Bronchopulmonary Dysplasia, Encephalomalacia | Phase 2 | Completed | Nationwide Children's Hospital | 64 | 2005-11-01 | 2013-08-30 |
Leukomalacia, Periventricular (8) · Premature Birth (5) · Brain Injuries (3) · Bronchopulmonary Dysplasia (3) · Cerebral Palsy (2) · Bacteremia (1) · Enterocolitis, Necrotizing (1) · Heart Defects, Congenital (1) · Intracranial Hemorrhages (1) · Psychomotor Disorders (1) · Retinopathy of Prematurity (1)
Brain Diseases (9) · Central Nervous System Diseases (9) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (9) · Infant, Newborn, Diseases (9) · Infant, Premature, Diseases (9) · Nervous System Diseases (9) · Cardiovascular Diseases (8) · Cerebrovascular Disorders (8) · Vascular Diseases (8) · Female Urogenital Diseases and Pregnancy Complications (5) · Obstetric Labor Complications (5) · Obstetric Labor, Premature (5) · Pregnancy Complications (5) · Urogenital Diseases (5)
Ampicillin (1) · Anti-Bacterial Agents (1) · Cefotaxime (1) · Erythropoietin (1) · Gentamicins (1) · Hydrocortisone (1) · Indomethacin (1) · Milk, Human (1) · Oxygen (1) · Progesterone (1) · Replens (1) · Saline Solution (1) · Sodium Chloride (1)
Atlantic Health System (1) · Children's Hospital of Philadelphia (1) · China Medical University Hospital (1) · Hong Huang (1) · Nationwide Children's Hospital (1) · Rohto Pharmaceutical Co., Ltd. (1) · Swiss Neonatal Network (1) · University of Chicago (1) · University of Florida (1)
United States (6) · Japan (1) · Switzerland (1) · Taiwan (1)
Bai-Horng Su, MD, PhD (1) · Hans U Bucher, Prof (1) · Hong Huang, MD-PhD (1) · J. William Gaynor, MD (1) · John Bauer, PhD (1) · Josef Neu, MD (1) · Michael D. Schreiber, M.D. (1) · Nehal A. Parikh, D.O., M.S. (1) · Sumito Okawa (1) · Vicki Whitehead, RN (1)
PMID 18676556, PMID 22776958, PMID 23140612, PMID 24969309, PMID 25157725, PMID 25534356, PMID 25863661, PMID 26376074, PMID 27187300, PMID 33479274, PMID 36477478, PMID 37308133, PMID 38805228, PMID 39373498
K23NS048152 (1), R01HD070792 (1), R21HD088005 (1)