Neuroprotective Effect of Autologous Cord Blood Combined With Therapeutic Hypothermia Following Neonatal Encephalopathy
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ClinicalTrials.gov Identifier: NCT02551003 |
Recruitment Status :
Recruiting
First Posted : September 16, 2015
Last Update Posted : March 9, 2022
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Condition or disease | Intervention/treatment | Phase |
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Hypoxic Ischemic Encephalopathy Cerebral Infarction | Drug: Autologous cord blood Device: Hypothermia | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | A Multi-Centre Safety and Efficacy Study of Autologous Cord Blood Combined With Therapeutic Hypothermia Following Neonates Encephalopathy in China |
Actual Study Start Date : | September 8, 2015 |
Estimated Primary Completion Date : | December 30, 2025 |
Estimated Study Completion Date : | December 30, 2025 |
Arm | Intervention/treatment |
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Experimental: Cord blood with hypothermia
Autologous cord blood will be collected after birth and stored in Cord Blood Bank of hospital. All cord blood samples are routinely performed by dedicated, trained UCB collection staff and is restricted to deliveries of mothers who have given prior written informed consent for collection. If the mother delivered a baby with signs of HIE or cerebral infarction, Bank staff collected UCB utilizing standard procedures. Collected UCB was transported at roomtemperature in validated shippers to the NICU. Infusions were started when cells and study staff were available for administration and monitoring. Infants received up to 3 infusions, with the first dose as soon as possible after birth, and at, 48, and 72 postnatal hours. 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.
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Drug: Autologous cord blood
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. |
Active Comparator: Hypothermia
Hypothermia therapy of cooling to 33.5 ℃ body temperature for 72 hours and standard intensive care.
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Device: Hypothermia
Hypothermia therapy of cooling to 33.5 ℃ body temperature for 72 hours and standard intensive care. |
- Mortality [ Time Frame: From birth to the age of 18 months ]The relative frequency of deaths in each group.
- Disability Rate [ Time Frame: From birth to the age of 18 months ]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.
- Neurodevelopment(Bayley Scores) [ Time Frame: At the age of 12 months ]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).
- Neurodevelopment(Bayley Scores) [ Time Frame: At the age of 18 months ]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).
- Brain Structural Alterations(MRI) [ Time Frame: At the age of 7 days ]Efficacy of cord blood by assessment of the changes in brain from baseline in MRI on Day 7.
- Brain Structural Alterations(MRI) [ Time Frame: At the age of 28 days ]Efficacy of cord blood by assessment of the changes in brain from baseline in MRI on Day 28.
- Brain Structural Alterations(MRI) [ Time Frame: At the age of 12 months ]Efficacy of cord blood by assessment of the changes in brain from baseline in MRI on 12 months old.
- Brain Parenchyma Alterations(MRI) [ Time Frame: At the age of 7 Days ]Efficacy of cord blood by assessment of the changes in brain from baseline in MRI on Day 7.
- Brain Parenchyma Alterations(MRI) [ Time Frame: At the age of 28 days ]Efficacy of cord blood by assessment of the changes in brain from baseline in MRI on Day 28.
- Brain Parenchyma Alterations(MRI) [ Time Frame: At the age of 12 months ]Efficacy of cord blood by assessment of the changes in brain from baseline in MRI on 12 months old.
- Intracranial Hemorrhage(MRI) [ Time Frame: At the age of 7 days ]Efficacy of cord blood by assessment of the changes in brain from baseline in MRI on Day 7.
- Intracranial Hemorrhage(MRI) [ Time Frame: At the age of Day 28 ]Efficacy of cord blood by assessment of the changes in brain from baseline in MRI on Day 7.
- Intracranial Hemorrhage(MRI) [ Time Frame: At the age of 12 months ]Efficacy of cord blood by assessment of the changes in brain from baseline in MRI on 12 months.
- Number of Adverse Events [ Time Frame: In 72 hours ]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.
- Number of Adverse Events(Blood Pressure) [ Time Frame: In 72 hours ]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.
- Number of Adverse Events(Pulse) [ Time Frame: In 72 hours ]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.
- Number of Adverse Events(Respiratory) [ Time Frame: In 72 hours ]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.
- Incidence of Complication [ Time Frame: From birth to the age of 28 days in each treatment period ]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.
- SDF-1 in Serum [ Time Frame: At the age of 4 days ]Biomarkers for Oxidative Stress, Inflammation and immune response as a measure of efficacy for hypoxic ischemic encephalopathy or cerebral infarction.
- SDF-1 in Serum [ Time Frame: At the age of 14 days ]Biomarkers for Oxidative Stress, Inflammation and immune response as a measure of efficacy for hypoxic ischemic encephalopathy or cerebral infarction.
- TNF-alpha in Serum [ Time Frame: At the age of 4 days ]Biomarkers for Oxidative Stress, Inflammation and immune response as a measure of efficacy for hypoxic ischemic encephalopathy or cerebral infarction.
- TNF-alpha in Serum [ Time Frame: At the age of 14 days ]Biomarkers for Oxidative Stress, Inflammation and immune response as a measure of efficacy for hypoxic ischemic encephalopathy or cerebral infarction.
- IL-1 in Serum [ Time Frame: At the age of 4 days ]Biomarkers for Oxidative Stress, Inflammation and immune response as a measure of efficacy for hypoxic ischemic encephalopathy or cerebral infarction.
- IL-1 in Serum [ Time Frame: At the age of 14 days ]Biomarkers for Oxidative Stress, Inflammation and immune response as a measure of efficacy for hypoxic ischemic encephalopathy or cerebral infarction.

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Ages Eligible for Study: | up to 24 Hours (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Gestational age ≥ 34 weeks
- Birth weight ≥ 1800 grams
- 10-minute Apgar score ≤5 or continued need for ventilation or severe acidosis, defined as pH <7.0
- Moderate to severe encephalopathy (Sarnat II to III)
- A moderately or severely abnormal background aEEG voltage, or seizures identified by aEEG, if monitored
- Up to 24 hours of age
- Autologous umbilical cord blood available to infuse 3 doses within 72 hours after birth
- Parental informed consent
Exclusion Criteria:
- Known major congenital anomalies, such as chromosomal anomalies, heart diseases
- Major intracranial hemorrhage identified by brain ultrasonography or computed tomography
- Severe intrauterine growth restriction (weight <1800g)
- Severe infectious disease, such as sepsis
- Inability to enroll by 24 hours of age
- Volume of collected cord blood <40 ml
- Infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist
- Parents refuse consent

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02551003
Contact: Wenhao Zhou, Doctor | zwhchfu@126.com | ||
Contact: Guoqiang Cheng, Doctor | gqchengcm@163.com |
China, Shanghai | |
Children Hospital of Fudan University | Recruiting |
Shanghai, Shanghai, China, 201102 | |
Contact: Wenhao Zhou, Doctor (+86)021-64931003 zwhchfu@126.com |
Study Chair: | Wenhao Zhou, Doctor | Children's Hospital of Fudan University |
Responsible Party: | Children's Hospital of Fudan University |
ClinicalTrials.gov Identifier: | NCT02551003 |
Obsolete Identifiers: | NCT02605018 |
Other Study ID Numbers: |
CHFudanU_NNICU1 |
First Posted: | September 16, 2015 Key Record Dates |
Last Update Posted: | March 9, 2022 |
Last Verified: | March 2022 |
Brain Diseases Cerebral Infarction Brain Ischemia Hypoxia-Ischemia, Brain Infarction Hypothermia Ischemia Pathologic Processes Necrosis Central Nervous System Diseases |
Nervous System Diseases Body Temperature Changes Hypoxia Signs and Symptoms, Respiratory Brain Infarction Cerebrovascular Disorders Stroke Vascular Diseases Cardiovascular Diseases Hypoxia, Brain |