Anemia, Neonatal, Cerebral Ischemia of Newborn, Hypoxia Neonatal, Hypoxic-Ischemic Encephalopathy
Conditions
Keywords
umbilical cord blood
Brief 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.
Interventions
BIOLOGICALautologous umbilical cord blood (UCB)
autologous UCB transfusion to the newborn infants presence of HIE and/or anemia within 48 hours after the birth
PROCEDUREstandard care
standard care procedure to the newborn infants presence of HIE and/or anemia
Sponsors
Chinese University of Hong Kong
China Spinal Cord Injury Network
Mononuclear Therapeutics Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Study Group - autologous umbilcial cord blood transfusion Control Group - standard care
Eligibility
Sex/Gender
ALL
Age
No minimum to 48 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anemia: Change from Baseline Hematocrit | 48 hours, 1 week, 3 months, 6 months | Change from Baseline Hematocrit of the Anemia Subjects |
| HIE: Mortality | 6 months | Mortality Rate of the HIE Subjects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HIE: HNNE | -1 day, 3 months (before discharge) | Hammersmith Neonatal Neurological Examination (HNNE) of the HIE Subjects |
| HIE: GMDS | 6 months, 1 year and 2 years | Griffiths Mental Development Scale (GMDS) of the HIE Subjects |
| HIE: CBCL | 2 years | Child Behavior Checklist for Attention Deficit of the HIE Subjects |
| HIE: Q-CHAT | 2 years | Quantitative Checklist for Autism in Toddlers of the HIE Subjects |
| Anemia: hemoglobin | 48 hours, 1 week, 3 months and 6 months | Change from Baseline hemoglobin of the Anemia Subjects |
| Anemia: Oxygenation level | 48 hours, 1 week | Change from Baseline SpO2 of the Anemia Subjects |
| Anemia: Oxidative Stress Level | 48 hours, 1 week, 3 months, and 6 months | Change of Baseline Isoprostane of the Anemia Subjects |
| Anemia: Requirements of Packed Cell Transfusion | 6 months | Frequency of Requirements of Packed Cell Transfusion by the Anemia Subjects |
| HIE: HINE | 6 months, 1 year and 2 years | Hammersmith Infant Neurological Examination (HINE) of the HIE Subjects |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Event | 2 years | Safety outcomes are Incidence of Adverse Events |
Countries
Hong Kong
Contacts
Primary ContactSimon Lam, MD
Backup ContactRonald Wang, MD
Outcome results
None listed