Neonatal Encephalopathy (Neonatal Hypoxic-ischemic Encephalopathy)
Conditions
Keywords
Neonatal encephalopathy, Hypoxic-ischemic encephalopathy, Newborn infants, Cytokines, Trophic factors
Brief summary
This is a observational study to assess the effects of and to explore the mechanisms of autologous umbilical cord blood cell therapy for neonatal encephalopathy by way of measuring serum cytokines.
Detailed description
The effects and mechanisms of umbilical cord blood cell therapy for perinatal brain injury are not well understood. This is a multicenter study to measure serum levels of inflammatory cytokines and trophic factors associated with perinatal brain injury and repair in term gestation newborns with neonatal encephalopathy (hypoxic-ischemic encephalopathy). This study proceeds along with the study Autologous cord blood cell therapy for neonatal encephalopathy (ClinicalTrials.gov identifier: NCT02256618). Blood samples are obtained before the first cell infusion, and subsequently 2h, 24h, 48h, and 7 days after the first cell infusion. Blood samples are obtained in the same manner from newborns with neonatal encephalopathy who are not receiving the cell therapy.
Interventions
BIOLOGICALAutologous cord blood cell therapy
The neonates receive their own non-cryopreserved volume- and red blood cell-reduced cord blood cells. The cord blood cells are divided into 3 doses and intravenously infused at 12-24, 36-48, and 60-72 hours after the birth.
Sponsors
Osaka City University
Yodogawa Christian Hospital
Kurashiki Central Hospital
Nagoya University
Osaka City General Hospital
Saitama Medical University
National Cerebral and Cardiovascular Center, Japan
National Center for Child Health and Development, Japan
Tokyo University
Tokyo Women's Medical University
Neonatal Encephalopathy Consortium, Japan
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Hours
Healthy volunteers
No
Inclusion criteria
Infants are eligible if they meet all the following inclusion criteria except 4. 1. ≥36 weeks gestation 2. Either a 10-minute Apgar score ≤5, continued need for resuscitation for at least 10 minutes, or severe acidosis, defined as pH \<7.0 or base deficit ≥16 mmol/L 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. A person with parental authority must have consented for the study.
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. Infants judged critically ill and unlikely to benefit from neonatal intensive care including hypothermia by the attending neonatologist
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in serum levels of cytokines and trophic factors | From birth up to 10 days of age |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Association with neuroimaging and neurodevelopmental functional outcome | 18 months | Neuroimaging at 12 months of age and neurodevelopmental function at 18 months of age will be assessed whether they are associated with serum levels of cytokines and trophic factors during the early neonatal period. |
Countries
Japan
Outcome results
None listed