Neonatal encephalopathy (Neonatal hypoxic-ischemic encephalopathy)
Conditions
Interventions
Intravenous infusions (up to 3 infusions) of autologous volume reduced cord blood cells in the first 72 hours after birth
Sponsors
Neonatal Encephalopathy Consortium, Japan
Saitama Medical Center Nagoya University Hospital Osaka City General Hospital Osaka City University Hospital Yodogawa Christian Hospital Kurashiki Central Hospital National Cerebral and Cardiovascular Center National Center for Child Health and Development The Institute of Medical Science, The University of Tokyo Yodogawa Christian Hospital Kurashiki Central Hospital National Cerebral and Cardiovascular Center National Center for Child Health and Development The Institu
s Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Infants are eligible if they meet all the following inclusion criteria except 4). 1) At least 36 weeks gestation 2) Either a 10-minute Apgar score 5 or less, continued need for resuscitation for at least 10 minutes, or severe acidosis, defined as pH <7.0 or base deficit 16 mmol/L or more in a sample of umbilical cord blood or any blood during the first hour after birth 3) Moderate to severe encephalopathy (Sarnat II to III) 4) A moderately or severely abnormal background amplitude-integrated EEG (aEEG) voltage, or seizures identified by aEEG, if monitored 5) Up to 24 hours of age 6) Autologous umbilical cord blood available to infuse within 3 days after birth 7) A person with parental authority must have consented for the study.
Exclusion criteria
Exclusion criteria: 1) Known major congenital anomalies, such as chromosomal anomalies, heart diseases 2) Major intracranial hemorrhage identified by brain ultrasonography or computed tomography 3) Severe growth restriction, with birth-weight less than 1800 g 4) Severe infectious disease, such as sepsis 5) Hyperkalemia 6) Outborn infants (Infants born at hospitals other than the study sites) 7) Volume of collected cord blood <40 ml 8) Infants judged critically ill and unlikely to benefit from neonatal intensive care by the attending neonatologist
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event rates (combined rate of death, continuous respiratory support, and continuous use of vasopressor) will be compared between the cell recipients and historical controls at 30 days of age. | — |
Secondary
| Measure | Time frame |
|---|---|
| Neuroimaging at 12 months of age and neurodevelopmental function at 18 months of age will be compared between the cell recipients and historical controls. | — |
Countries
Japan
Contacts
Public ContactMakoto Nabetani
Yodogawa Christian Hospital Hospice-Children's Hospice Hospital
Outcome results
None listed