A Multi-site Study of Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy ((HIE))
Moderate or Severe Hypoxic-ischemic Encephalopathy in Newborns
About this trial
This is an interventional treatment trial for Moderate or Severe Hypoxic-ischemic Encephalopathy in Newborns focused on measuring Hypoxic-ischemic encephalopathy, autologous cord blood cells, newborn infants
Eligibility Criteria
Inclusion Criteria:
- NICHD Neonatal Research Network Hypothermia Trial inclusion criteria
- Mothers must have consented or given verbal assent for cord blood collection at delivery, and cord blood must be available for volume and red blood cell reduction before 45 hours of age
- The infant must be able to receive at least one dose of autologous cord blood before 48 hours of age
- All infants must have signs of encephalopathy within 6 hours of age
Exclusion Criteria:
- Major congenital or chromosomal abnormalities
- Severe growth restriction (birth weight <1800 g)
- Opinion by attending neonatologist that the study may interfere with treatment or safety of subject
- Moribund neonates for whom no further treatment is planned
- Infants born to mothers are known to be HIV, Hepatitis B, Hepatitis C or who have active syphilis or CMV infection in pregnancy
- Infants suspected of overwhelming sepsis
- ECMO initiated or likely in the first 48 hours of life
Sites / Locations
- University of Alabama Birmingham
- University of Florida Gainesville
- MassGeneral Hospital for Children
- Brigham and Women's Hospital
- Wayne State University Hospital
- Duke University Medical Center
- University of Florida at Jacksonville
- Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Intervention cell recipients
Placebo recipients
Experimental: infusions: infants with moderate to severe hypoxic ischemic encephalopathy, begin cooling, and have autologous nucleated cord blood cells available for infusion will receive up to two infusions. Outcomes will be measured at 22-26 months by neurodevelopment assessment
Control: infants with moderate to severe hypoxic ischemic encephalopathy, begin cooling, and have cord blood available for infusion will receive placebo (a mix of autologous cord blood red blood cells and plasma) infusions. Outcomes will be measured at 22-26 months by neurodevelopment assessment