Trial | NCT03352310  Report issue

Title

Feasibility and Safety of Umbilical Cord Blood Transfusion in the Treatment of Neonatal Cerebral Ischemia and Anemia
Umbilical Cord Blood Mononuclear Cell Bank in Hong Kong and Treatment of Neonatal Cerebral Ischemia and Anemia - Part IV Clinical Trial

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    40
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.
Study Started
Apr 16
2018
Primary Completion
Jun 30
2020
Anticipated
Study Completion
Dec 30
2020
Anticipated
Last Update
Jun 07
2018

Biological autologous umbilical cord blood (UCB)

autologous UCB transfusion to the newborn infants presence of HIE and/or anemia within 48 hours after the birth

Procedure standard care

standard care procedure to the newborn infants presence of HIE and/or anemia

Study Group Experimental

autologous UCB transfusion

Control Group Other

standard care

Criteria 

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
No Results Posted