Adverse event rates occurring in the pilot study population will be compared between the cord blood cell recipients and historical controls.
Secondary endpoints of this pilot study will include preliminary efficacy as measured by neurodevelopmental function at 4 - 6 months and 9 - 12 months of age
neuroimaging results will be collected and compared with available results from prior trials of therapies in this population, and from a previously collected set of images from normal term newborns through the first year of life.
up to 14 Days (Child)
Pro00000412 Duke NPRI01
January 14, 2008
March 21, 2017
Duke University Durham, North Carolina, United States
† Study has passed its completion date and status has not been verified in more than two years.