This study examines the effect of cord blood in the treatment of newborn infants with neonatal encephalopathy in combination with hypothermia, which is the standard treatment for this condition. The hypothesis is that the cord blood + hypothermia combination will produce better neuroprotection than the standard treatment of hypothermia alone.
The primary aim of this study is to determine the neuroprotective effect of intravenous administration of autologous cord blood in neonates with severe encephalopathy (hypoxic ischemic encephalopathy or cerebral infarction). It is hypothesized that the administration of autologous cord blood will be safe and well tolerated in neonates with severe encephalopathy. If a neonate is born with signs of moderate to severe encephalopathy and cooled for the encephalopathy, the neonate will receive their own cord blood. The cord blood cells are divided into 3 doses and infused at 24, 48, and 72 hours after the birth. Infants will be randomised to treatment with autologous cord blood and hypothermia or hypothermia only and followed for safety and neurodevelopmental outcome up to 18 months. All infants in both groups will be treated with hypothermia for 72 hours started within 6 hours of delivery and infants who allocated to hypothermia and xenon will also receive autologous cord blood in 24 hours from birth through a purpose designed delivery system. Additionally, postnatal neuro-developmental outcomes in neonates with encephalopathy after autologous cord blood therapy will be measured; HIE injury to the neonate/infant brain post autologous cord blood therapy by imaging will be characterized; MRI's will be obtained per clinical routine; serum levels of selected cytokine and neurotrophic factors in neonates with HIE before and after autologous cord blood therapy will be compared and immune cell phenotype and function in neonates with HIE before and after autologous cord blood therapy will be compared.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Autologous cord blood will be collected after birth and administered in divided aliquots during the first 3 days of life. At the same time, babies will referred to neonatal intensive care unit for hypothermia therapy of cooling to 33.5 ℃ body temperature for 72 hours and standard intensive care.
Hypothermia therapy of cooling to 33.5 ℃ body temperature for 72 hours and standard intensive care.
Children Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Mortality
The relative frequency of deaths in each group.
Time frame: From birth to the age of 18 months
Disability Rate
Disability, defined as a physical or mental handicap, especially one that prevents a person from living a full, normal life or from holding a gainful job.
Time frame: From birth to the age of 18 months
Neurodevelopment(Bayley Scores)
Efficacy of levetiracetam by assessment of the change from baseline to 12 months in neurodevelopment via Bayley Scores of Infant Development Mental Development Index (BSID).
Time frame: At the age of 12 months
Neurodevelopment(Bayley Scores)
Efficacy of levetiracetam by assessment of the change from baseline to 18 months in neurodevelopment via Bayley Scores of Infant Development Mental Development Index (BSID).
Time frame: At the age of 18 months
Brain Structural Alterations(MRI)
Efficacy of cord blood by assessment of the changes in brain from baseline in MRI on Day 7.
Time frame: At the age of 7 days
Brain Structural Alterations(MRI)
Efficacy of cord blood by assessment of the changes in brain from baseline in MRI on Day 28.
Time frame: At the age of 28 days
Brain Structural Alterations(MRI)
Efficacy of cord blood by assessment of the changes in brain from baseline in MRI on 12 months old.
Time frame: At the age of 12 months
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Brain Parenchyma Alterations(MRI)
Efficacy of cord blood by assessment of the changes in brain from baseline in MRI on Day 7.
Time frame: At the age of 7 Days
Brain Parenchyma Alterations(MRI)
Efficacy of cord blood by assessment of the changes in brain from baseline in MRI on Day 28.
Time frame: At the age of 28 days
Brain Parenchyma Alterations(MRI)
Efficacy of cord blood by assessment of the changes in brain from baseline in MRI on 12 months old.
Time frame: At the age of 12 months
Intracranial Hemorrhage(MRI)
Efficacy of cord blood by assessment of the changes in brain from baseline in MRI on Day 7.
Time frame: At the age of 7 days
Intracranial Hemorrhage(MRI)
Efficacy of cord blood by assessment of the changes in brain from baseline in MRI on Day 7.
Time frame: At the age of Day 28
Intracranial Hemorrhage(MRI)
Efficacy of cord blood by assessment of the changes in brain from baseline in MRI on 12 months.
Time frame: At the age of 12 months
Number of Adverse Events
This is a composition of general appearance includes abdomen, skin, head and neck (including ears, eyes, nose, and throat), lymph nodes, thyroid, musculoskeletal and neurological systems.
Time frame: In 72 hours
Number of Adverse Events(Blood Pressure)
This is a composition of general appearance, blood pressure, pulse, respiratory, cardiovascular, abdomen, skin, head and neck (including ears, eyes, nose, and throat), lymph nodes, thyroid, musculoskeletal and neurological systems.
Time frame: In 72 hours
Number of Adverse Events(Pulse)
This is a composition of general appearance, blood pressure, pulse, respiratory, cardiovascular, abdomen, skin, head and neck (including ears, eyes, nose, and throat), lymph nodes, thyroid, musculoskeletal and neurological systems.
Time frame: In 72 hours
Number of Adverse Events(Respiratory)
This is a composition of general appearance, blood pressure, pulse, respiratory, cardiovascular, abdomen, skin, head and neck (including ears, eyes, nose, and throat), lymph nodes, thyroid, musculoskeletal and neurological systems.
Time frame: In 72 hours
Incidence of Complication
To gain the incidence of Polycythemia, neutropenia, thrombocytopenia, hypertension, sepsis, intraventricular hemorrhage(IVH), periventricular leukomalacia(PVL), seizure, necrotizing enterocolitis (NEC), persistent ductus arterious (PDA), apnea of prematurity, pulmonary haemorrhage, pulmonary hypertension, Prolonged blood coagulation time, retinopathy of prematurity(ROP), cardiac arrhythmia, major venous thrombosis, Renal failure treated with dialysis, pneumonia, pulmonary airleak and chronic lung disease.
Time frame: From birth to the age of 28 days in each treatment period
SDF-1 in Serum
Biomarkers for Oxidative Stress, Inflammation and immune response as a measure of efficacy for hypoxic ischemic encephalopathy or cerebral infarction.
Time frame: At the age of 4 days
SDF-1 in Serum
Biomarkers for Oxidative Stress, Inflammation and immune response as a measure of efficacy for hypoxic ischemic encephalopathy or cerebral infarction.
Time frame: At the age of 14 days
TNF-alpha in Serum
Biomarkers for Oxidative Stress, Inflammation and immune response as a measure of efficacy for hypoxic ischemic encephalopathy or cerebral infarction.
Time frame: At the age of 4 days
TNF-alpha in Serum
Biomarkers for Oxidative Stress, Inflammation and immune response as a measure of efficacy for hypoxic ischemic encephalopathy or cerebral infarction.
Time frame: At the age of 14 days
IL-1 in Serum
Biomarkers for Oxidative Stress, Inflammation and immune response as a measure of efficacy for hypoxic ischemic encephalopathy or cerebral infarction.
Time frame: At the age of 4 days
IL-1 in Serum
Biomarkers for Oxidative Stress, Inflammation and immune response as a measure of efficacy for hypoxic ischemic encephalopathy or cerebral infarction.
Time frame: At the age of 14 days