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

Mononuclear Therapeutics Ltd.40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypoxic-Ischemic Encephalopathy Hypoxia Neonatal Cerebral Ischemia of Newborn Anemia, Neonatal

Eligibility

Sex: ALLMax age: 48 Hours

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

HIE: Mortality

Mortality Rate of the HIE Subjects

Time frame: 6 months

Anemia: Change from Baseline Hematocrit

Change from Baseline Hematocrit of the Anemia Subjects

Time frame: 48 hours, 1 week, 3 months, 6 months

Secondary Outcomes

HIE: HINE

Hammersmith Infant Neurological Examination (HINE) of the HIE Subjects

Time frame: 6 months, 1 year and 2 years

HIE: HNNE

Hammersmith Neonatal Neurological Examination (HNNE) of the HIE Subjects

Time frame: -1 day, 3 months (before discharge)

HIE: GMDS

Griffiths Mental Development Scale (GMDS) of the HIE Subjects

Time frame: 6 months, 1 year and 2 years

HIE: CBCL

Child Behavior Checklist for Attention Deficit of the HIE Subjects

Time frame: 2 years

HIE: Q-CHAT

Quantitative Checklist for Autism in Toddlers of the HIE Subjects

Time frame: 2 years

Anemia: hemoglobin

Change from Baseline hemoglobin of the Anemia Subjects

Time frame: 48 hours, 1 week, 3 months and 6 months

Anemia: Oxygenation level

Change from Baseline SpO2 of the Anemia Subjects

Time frame: 48 hours, 1 week

Anemia: Oxidative Stress Level

Change of Baseline Isoprostane of the Anemia Subjects

Time frame: 48 hours, 1 week, 3 months, and 6 months

Anemia: Requirements of Packed Cell Transfusion

Frequency of Requirements of Packed Cell Transfusion by the Anemia Subjects