Neuroprotective Effect of Autologous Cord Blood Combined With Therapeutic Hypothermia Following Neonatal Encephalopathy
Hypoxic Ischemic Encephalopathy, Cerebral Infarction
About this trial
This is an interventional treatment trial for Hypoxic Ischemic Encephalopathy
Eligibility Criteria
Inclusion Criteria:
- Gestational age ≥ 34 weeks
- Birth weight ≥ 1800 grams
- 10-minute Apgar score ≤5 or continued need for ventilation or severe acidosis, defined as pH <7.0
- Moderate to severe encephalopathy (Sarnat II to III)
- A moderately or severely abnormal background aEEG voltage, or seizures identified by aEEG, if monitored
- Up to 24 hours of age
- Autologous umbilical cord blood available to infuse 3 doses within 72 hours after birth
- Parental informed consent
Exclusion Criteria:
- Known major congenital anomalies, such as chromosomal anomalies, heart diseases
- Major intracranial hemorrhage identified by brain ultrasonography or computed tomography
- Severe intrauterine growth restriction (weight <1800g)
- Severe infectious disease, such as sepsis
- Inability to enroll by 24 hours of age
- Volume of collected cord blood <40 ml
- Infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist
- Parents refuse consent
Sites / Locations
- Children Hospital of Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Cord blood with hypothermia
Hypothermia
Autologous cord blood will be collected after birth and stored in Cord Blood Bank of hospital. All cord blood samples are routinely performed by dedicated, trained UCB collection staff and is restricted to deliveries of mothers who have given prior written informed consent for collection. If the mother delivered a baby with signs of HIE or cerebral infarction, Bank staff collected UCB utilizing standard procedures. Collected UCB was transported at roomtemperature in validated shippers to the NICU. Infusions were started when cells and study staff were available for administration and monitoring. Infants received up to 3 infusions, with the first dose as soon as possible after birth, and at, 48, and 72 postnatal hours. At the same time, babies will referred to neonatal intensive care unit for hypothermia therapy of cooling to 33.5 ℃ body temperature for 72 hours and standard intensive care.
Hypothermia therapy of cooling to 33.5 ℃ body temperature for 72 hours and standard intensive care.