| Study name |
A pilot feasibility and safety study of autologous umbilical cord blood cell therapy in infants with neonatal encephalopathy. |
| Methods |
Multicentre pilot study; comparison with historical controls. |
| Participants |
Inclusion criteria: infants are eligible if they meet all the following inclusion criteria except 4):
At least 36 weeks' gestation 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 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 criteria
Known major congenital anomalies Major intracranial haemorrhage identified by brain ultrasonography or computed tomography Severe growth restriction, with birth‐weight less than 1800 g Severe infectious disease, such as sepsis Hyperkalaemia Outborn infants Volume of collected cord blood < 40 ml Infants judged critically ill and unlikely to benefit from neonatal intensive care by the attending neonatologist
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| Interventions |
Intravenous infusions (up to 3 infusions) of autologous volume reduced cord blood cells in the first 72 hours after birth. The neonate can receive their own non‐cryopreserved volume‐ and red blood cell‐reduced cord blood cells. The cord blood cells are divided into 3 doses and infused at 12 to 24, 36 to 48, and 60 to 72 hours after the birth. |
| Outcomes |
Primary outcome: adverse event rates (combined rate of death, continuous respiratory support, and continuous use of vasopressor) Secondary outcomes: neuroimaging at 12 months of age and neurodevelopmental function at 18 months of age |
| Starting date |
1 August 2014 |
| Contact information |
Makoto Nabetani, a103111@ych.or.jp, Yodogawa Christian Hospital, Osaka, Japan |
| Notes |
Study sponsor: Neonatal Encephalopathy Consortium, Japan |
