NCT02612155.

Study name	A multi‐site study of autologous cord blood cells for hypoxic ischaemic encephalopathy
Methods	Multicenter phase 2 RCT
Participants	Estimated sample size: 160 newborns 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 1 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
Interventions	Intervention: autologous nucleated cord blood cells available for infusion (up to 2 infusions) Control: mix of autologous cord blood red blood cells and plasma
Outcomes	Primary outcomes: survival at 1 year; percentage of subjects with Bayley III scores in all 3 domains ≥ to 85 Secondary outcomes:  percentage of infants with seizures, iNO use; need for ECMO; G‐tube feeding; anti‐epileptic medications
Starting date	20 March 2017
Contact information	Kimberley A Fisher, kimberley.fisher@duke.edu, Duke University Medical Center, Durham, North Carolina, USA
Notes	Study sponsor: Michael Cotton