Neonatal hypoxic ischemic encephalopathy
Conditions
Interventions
Autologous cord blood stem cell preparation solution intravenous administration
Sponsors
OHNISHI SATOSHI
SHINTAKU HARUO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At the time of enrollment, subjects who meet all the following selection criteria but do not fall under any of the exclusion criteria are eligible. 1. Born over 36 weeks of gestational age. Match one of the following: 1) Apgar score of 10 minutes after birth is 5 or less. 2) Continuous neonatal resuscitation of 10 minutes or more is necessary. 3) Severe acidosis (pH less than 7.0 , or base deficit more than 16 mmol/L in blood gas) at birth (within 1 hour of birth). 3. Moderate or severe encephalopathy (Sarnat classification II to III degree) or seizure are recognized. 4. Autologous cord blood is collected and stored, and cord blood can be administered within 12~24 hours after birth. 5. Written consent has been obtained from the parent of the patient.
Exclusion criteria
Exclusion criteria: 1. Head echo or CT shows severe intracranial hemorrhage. 2. Birth weight is less than 1800g. 3. Serious infections are occurring. 4. Cord blood collection volume is less than 40 ml. 5. I am dying and I can not expect the benefit of the child by intensive care including hypothermia. Or, at the discretion of the attending physician, entry into this study may be considered inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Development index by new edition K type developmental test to evaluate from 1 year 6 months to 2 year of age | — |
Secondary
| Measure | Time frame |
|---|---|
| Head MRI to evaluate at 7~14 days of age and at from 1 year to 1year 6 months of age | — |
Countries
Japan
Contacts
Public ContactNabetani Makoto
Yodogawa Christian Hospital
Outcome results
None listed