This is a pilot study to test feasibility and safety of collection, preparation and infusion of a baby's own (autologous) umbilical cord blood during the first 3 days of age if the baby is born with signs of brain injury. The cord blood used is fresh (not frozen and then thawed).
The purpose of this pilot study is to evaluate the safety and feasibility of infusions of autologous (the patient's own) umbilical cord blood cells in term gestation newborn infants with hypoxic-ischemic encephalopathy. For this study, infants who have signs of moderate to severe encephalopathy at birth and have cord blood collected at birth can receive their own cord blood cells during the 3 days of age. Babies will be followed for neurodevelopmental outcome at 1, 4 - 6, 9 - 12 months and 18-24 months. MRI brain will be obtained at 1-2 weeks and 4-6 months old.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Baby's own umbilical cord blood
National University Hospital
Singapore, Singapore
KK Women's and Children's Hospital
Singapore, Singapore
Singapore General Hospital
Singapore, Singapore
Safety
Adverse event rates occurring in the recipients
Time frame: 1-3 days of age
Neurodevelopment
Peabody tests, Bayley Scales of Infant Development
Time frame: 1 month-2 years old
Brain imaging
MRI brain at 1-2 weeks old and 4-6 months old
Time frame: 1 week-6 months
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