Phase
Condition
Neurologic Disorders
Stroke
Cerebral Palsy
Treatment
N/AClinical Study ID
Ages < 24 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Infants are eligible if they meet all the following inclusion criteria except 4.
≥36 weeks gestation
Either a 10-minute Apgar score ≤5, continued need for resuscitation for at least 10minutes, or severe acidosis, defined as pH <7.0 or base deficit ≥16 mmol/L in a sampleof umbilical cord blood or any blood during the first hour after birth
Moderate to severe encephalopathy (Sarnat II to III)
A moderately or severely abnormal background amplitude-integrated EEG (aEEG) voltage,or seizures identified by aEEG, if monitored
Up to 24 hours of age
Autologous umbilical cord blood available to infuse within 3 days after birth
A person with parental authority must have consented for the study.
Exclusion
Exclusion Criteria:
Known major congenital anomalies, such as chromosomal anomalies, heart diseases
Major intracranial hemorrhage identified by brain ultrasonography or computedtomography
Severe growth restriction, with birth-weight less than 1800 g
Severe infectious disease, such as sepsis
Hyperkalemia
Outborn infants (Infants born at hospitals other than the study sites)
Volume of collected cord blood <40 ml
Infants judged critically ill and unlikely to benefit from neonatal intensive care bythe attending neonatologist
Study Design
Study Description
Connect with a study center
Nagoya University Hospital
Nagoya, Aichi 466-8560
JapanSite Not Available
Kurashiki Central Hospital
Kurashiki, Okayama 710-8602
JapanSite Not Available
Saitama Medical University
Kawagoe, Saitama 350-0495
JapanSite Not Available
Osaka City General Hospital
Osaka, 534-0021
JapanSite Not Available
Osaka City University
Osaka, 545-8585
JapanSite Not Available
Yodogawa Christian Hospital
Osaka, 533-0032
JapanSite Not Available
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