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. 2020 Aug 19;2020(8):CD013202. doi: 10.1002/14651858.CD013202.pub2

NCT01649648.

Study name Autologous cord blood cells for brain injury in term newborns
Methods Phase 1, open‐label, single group assignment study
Participants Estimated sample size = 10
Inclusion criteria
  • Autologous umbilical cord blood available

  • > 36 weeks' gestation

  • Brain injury that satisfies criteria for therapeutic hypothermia

  • Parental informed consent

Interventions Autologous cord blood infusion
Outcomes Primary outcome: adverse event rates occurring in the recipients within the 3 first days of life.
Secondary outcomes
  • Neurodevelopmental assessment (Peabody tests, Bayley Scales of Infant Development) with time frame 1 month to 2 years

  • MRI brain at 1 to 2 weeks old and 4 to 6 months old (kind of analysis is not defined)

Starting date September 2011
Contact information Principal Investigator: Jiun Lee, MBBS, National University Hospital, Singapore
Principal Investigator: Samuel Rajadurai, MBBS, KK Women's and Children's Hospital
Principal Investigator: Cheo Lian Yeo, MBBS, Singapore General Hospital
Notes Study sponsor:  National University Hospital, Singapore