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

Study Overview
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Brief Summary
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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.

Official Title
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Umbilical Cord Blood Mononuclear Cell Bank in Hong Kong and Treatment of Neonatal Cerebral Ischemia and Anemia - Part IV Clinical Trial

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

Intervention / Treatment
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* Biological: autologous umbilical cord blood (UCB)
* Procedure: standard care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 48 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Study Group - autologous umbilcial cord blood transfusion Control Group - standard care
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>autologous UCB transfusion | Biological: autologous umbilical cord blood (UCB)<br>* autologous UCB transfusion to the newborn infants presence of HIE and/or anemia within 48 hours after the birth<br>|
| Other: Control Group<br>standard care | Procedure: standard care<br>* standard care procedure to the newborn infants presence of HIE and/or anemia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIE: Mortality | Mortality Rate of the HIE Subjects | 6 months | 
| Anemia: Change from Baseline Hematocrit | Change from Baseline Hematocrit of the Anemia Subjects | 48 hours, 1 week, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIE: HINE | Hammersmith Infant Neurological Examination (HINE) of the HIE Subjects | 6 months, 1 year and 2 years | 
| HIE: HNNE | Hammersmith Neonatal Neurological Examination (HNNE) of the HIE Subjects | -1 day, 3 months (before discharge) | 
| HIE: GMDS | Griffiths Mental Development Scale (GMDS) of the HIE Subjects | 6 months, 1 year and 2 years | 
| HIE: CBCL | Child Behavior Checklist for Attention Deficit of the HIE Subjects | 2 years | 
| HIE: Q-CHAT | Quantitative Checklist for Autism in Toddlers of the HIE Subjects | 2 years | 
| Anemia: hemoglobin | Change from Baseline hemoglobin of the Anemia Subjects | 48 hours, 1 week, 3 months and 6 months | 
| Anemia: Oxygenation level | Change from Baseline SpO2 of the Anemia Subjects | 48 hours, 1 week | 
| Anemia: Oxidative Stress Level | Change of Baseline Isoprostane of the Anemia Subjects | 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 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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umbilical cord blood