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| Name | Class |
|---|---|
| Chinese University of Hong Kong | OTHER |
| China Spinal Cord Injury Network | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Experimental | autologous UCB transfusion |
|
| Control Group | Other | standard care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous umbilical cord blood (UCB) | Biological | autologous UCB transfusion to the newborn infants presence of HIE and/or anemia within 48 hours after the birth |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Event | Safety outcomes are Incidence of Adverse Events | 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Simon Lam, MD | Contact | +852 35052851 | hshslam@cuhk.edu.hk | |
| Ronald Wang, MD | Contact | +852 35052810 |
| Name | Affiliation | Role |
|---|---|---|
| Simon Lam, MD | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chinese University of Hong Kong | Recruiting | Shatin | Hong Kong |
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Study Group - autologous umbilcial cord blood transfusion
Control Group - standard care
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| standard care | Procedure | standard care procedure to the newborn infants presence of HIE and/or anemia |
|
| -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 |
| ID | Term |
|---|---|
| D020925 | Hypoxia-Ischemia, Brain |
| D001238 | Asphyxia Neonatorum |
| D000751 | Anemia, Neonatal |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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