NCT02854579.

Study name	Neural progenitor cell and paracrine factors to treat hypoxic ischaemic encephalopathy
Methods	Open‐label randomised interventional study
Participants	Inclusion criteria Gestational age ≥ 34 weeks, body weight ≥ 2 kg 1 minute Apgar score ≤ 3, and 5 minutes Apgar score ≤ 5; or umbilical arterial blood gas potential of hydrogen < 7.0; or 30 minutes base excess ≤ −12 mmol/L; or need for ventilation 5 minutes after birth. All infants must have signs of encephalopathy (such as convulsion, coma, dystonia, abnormal primitive reflex and irregular respiration) within 6 hours of age or continued abnormal EEG for more than 24 h.
Interventions	Intervention: neural progenitor cell: 3 doses of neural progenitor cell (4*10⁶) intrathecally at 48 to 72 h, 5 d and 10 d after birth + routine therapy Intervention:  paracrine factors: 3 doses of concentrated paracrine factors of human mesenchymal stem cell (0.5 ml) intrathecally at 12 h, 24 h, 48 h after birth + routine therapy Intervention: neural progenitor cell and paracrine factors:  3 doses of concentrated paracrine factors 0.5 ml intrathecally at 12h, 24h, 48h after birth. And 3 doses of neural progenitor cell (4*10⁶) intrathecally at 48 to 72 h, 5 d and 10 d after birth + routine therapy No intervention:  routine therapy
Outcomes	Sample size 120 neonates, up to 14 days of life Primary outcomes Neonatal Behavioral Neurological Assessment at 14 days and at 28 days of life Number of adverse events 7 days following cells/factor injection (fever, infection, seizures, haemorrhage coursed by interventions) Secondary outcomes Bayley score at 12 months and 18 month after birth Peabody development measure scale at 12 months and 18 months after birth Number of death within  1 years after birth  Number of participants with treatment‐related central nervous tumour as assessed by Magnetic Resonance Imaging or CT within 5 years after birth
Starting date	January 2013
Contact information	Study Chair: Zuo Luan, MD, Navy General Hospital
Notes	Study sponsor: Navy General Hospital, Beijing