UnknownPhase 1

Feasibility and Safety of Umbilical Cord Blood Transfusion in the Treatment of Neonatal Cerebral Ischemia and Anemia

Hong Kong40 participantsStarted 2018-04-16

Plain-language summary

The study is to investigate the feasibility and safety of autologous umbilical cord blood transfusion to treat the newborn infants with presence of clinical indications of neonatal hypoxic-ischemia encephalopathy (HIE) and anemia. Umbilical cord blood (UCB) is collected following labor and is transfused intravenously within 48 hours after the birth. Newborn infant without UCB available recieves the standard care will be enrolled as control group. Following the autologous UCB transfusion in the study group or standard care in the control group, HIE subjects will be followed for 2 years for survival and neurodevelopmental outcomes and anemia subjects will be followed for 6 months to assess the survival and change of hematocrit and hemoglobin levels.

Who can participate

Age range48 Hours

SexALL

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Inclusion Criteria: * evidence of asphyxiation, defined by 5-minute Apgar score ≤ 5; * evidence of HIE, defined by UCB pH \<7.15 or base excess ≤ 10mM; * subjects with HIE confirmed by clinical features and initial investigations; * subjects with evidence of anemia, defined by hematocrit \< 40% or hemoglobin ≤ 13g/dL within the first 96 hours of life; * obtain the informed consent from parents Exclusion Criteria: * congestive cardiac failure; * microcephaly, anencephaly, encephalocele, or other abnormality * conjoint twins; * chromosomal disorders * fetal alcohol syndrome * spinal bifida or other neural tube defects * subjects have other neurological deficit conditions * polycythemia * congenital hematological malignancy * investigator decision

What they're measuring

HIE: Mortality

Timeframe: 6 months

Anemia: Change from Baseline Hematocrit

Timeframe: 48 hours, 1 week, 3 months, 6 months

Trial details

NCT IDNCT03352310

SponsorMononuclear Therapeutics Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-06-30

Contact for this trial

Simon Lam, MD

+852 35052851 hshslam@cuhk.edu.hk