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

NCT03352310.

Study name Feasibility and safety of umbilical cord blood transfusion in the treatment of neonatal cerebral ischemia and anaemia
Methods Phase 1, non‐randomised trial with parallel assignment
Participants Expected sample size = 40
Inclusion criteria

  • Evidence of asphyxiation, defined by 5‐minute Apgar score ≤ 5;

  • Evidence of HIE, defined by UCB pH < 7.15 or base excess ≤ 10 mM;

  • Subjects with HIE confirmed by clinical features and initial investigations;

  • Subjects with evidence of anaemia, defined by haematocrit < 40% or haemoglobin ≤ 13 g/dL within the first 96 hours of life;

  • Obtain the informed consent from parents
Interventions

  • Intervention group: autologous UCB transfusion to the newborn infants presence of HIE and/or anaemia within 48 hours after the birth

  • Standard care group: standard care procedure to the newborn infants presence of HIE and/or anaemia
Outcomes Primary outcomes

  • HIE: Mortality ‒ mortality rate of the HIE Subjects [time frame: 6 months]

  • Anaemia: change from baseline haematocrit [time frame: 48 hours, 1 week, 3 months, 6 months]


Secondary outcomes

  • HIE

    • Hammersmith Infant Neurological Examination (HINE) of the HIE Subjects [time frame: 6 months, 1 year and 2 years]

    • Hammersmith Neonatal Neurological Examination (HNNE) of the HIE Subjects [time frame: ‐1 day, 3 months (before discharge)]

    • Griffiths Mental Development Scale (GMDS) of the HIE Subjects [time frame: 6 months, 1 year and 2 years

    • Child Behavior Checklist for Attention Deficit (CBCL) of the HIE Subjects [time frame: 2 years]

    • Quantitative Checklist for Autism in Toddlers (Q‐CHAT) of the HIE Subjects [time frame: 2 years]


Anaemia

  • Change from baseline haemoglobin of the anaemia subjects [time frame: 48 hours, 1 week, 3 months and 6 months]

  • Change from baseline SpO2 of the anaemia subjects [time frame: 48 hours, 1 week]

  • Change of baseline Isoprostane of the anaemia subjects [time frame: 48 hours, 1 week, 3 months, and 6 months]

  • Frequency of requirements of packed cell transfusion by the anaemia subjects [time frame: 6 months]
Starting date April 2018
Contact information Principal Investigator: Simon Lam, MD; Chinese University of Hong Kong
Notes Study sponsor: Mononuclear Therapeutics Ltd.