Cerebral Infarction Clinical Trial
Official title:
A Multi-Centre Safety and Efficacy Study of Autologous Cord Blood Combined With Therapeutic Hypothermia Following Neonates Encephalopathy in China
Verified date | December 2023 |
Source | Children's Hospital of Fudan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 30, 2016 |
Est. primary completion date | December 30, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 24 Hours |
Eligibility | Inclusion Criteria: 1. Gestational age = 34 weeks 2. Birth weight = 1800 grams 3. 10-minute Apgar score =5 or continued need for ventilation or severe acidosis, defined as pH <7.0 4. Moderate to severe encephalopathy (Sarnat II to III) 5. A moderately or severely abnormal background aEEG voltage, or seizures identified by aEEG, if monitored 6. Up to 24 hours of age 7. Autologous umbilical cord blood available to infuse 3 doses within 72 hours after birth 8. Parental informed consent Exclusion Criteria: 1. Known major congenital anomalies, such as chromosomal anomalies, heart diseases 2. Major intracranial hemorrhage identified by brain ultrasonography or computed tomography 3. Severe intrauterine growth restriction (weight <1800g) 4. Severe infectious disease, such as sepsis 5. Inability to enroll by 24 hours of age 6. Volume of collected cord blood <40 ml 7. Infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist 8. Parents refuse consent |
Country | Name | City | State |
---|---|---|---|
China | Children Hospital of Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Fudan University | Guangzhou Women and Children's Medical Center, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region |
China,
Cotten CM, Murtha AP, Goldberg RN, Grotegut CA, Smith PB, Goldstein RF, Fisher KA, Gustafson KE, Waters-Pick B, Swamy GK, Rattray B, Tan S, Kurtzberg J. Feasibility of autologous cord blood cells for infants with hypoxic-ischemic encephalopathy. J Pediatr. 2014 May;164(5):973-979.e1. doi: 10.1016/j.jpeds.2013.11.036. Epub 2013 Dec 31. — View Citation
Liao Y, Cotten M, Tan S, Kurtzberg J, Cairo MS. Rescuing the neonatal brain from hypoxic injury with autologous cord blood. Bone Marrow Transplant. 2013 Jul;48(7):890-900. doi: 10.1038/bmt.2012.169. Epub 2012 Sep 10. — View Citation
Pimentel-Coelho PM, Rosado-de-Castro PH, da Fonseca LM, Mendez-Otero R. Umbilical cord blood mononuclear cell transplantation for neonatal hypoxic-ischemic encephalopathy. Pediatr Res. 2012 Apr;71(4 Pt 2):464-73. doi: 10.1038/pr.2011.59. Epub 2012 Feb 8. — View Citation
Walsh BH, Boylan GB, Livingstone V, Kenny LC, Dempsey EM, Murray DM. Cord blood proteins and multichannel-electroencephalography in hypoxic-ischemic encephalopathy. Pediatr Crit Care Med. 2013 Jul;14(6):621-30. doi: 10.1097/PCC.0b013e318291793f. — View Citation
Walsh BH, Broadhurst DI, Mandal R, Wishart DS, Boylan GB, Kenny LC, Murray DM. The metabolomic profile of umbilical cord blood in neonatal hypoxic ischaemic encephalopathy. PLoS One. 2012;7(12):e50520. doi: 10.1371/journal.pone.0050520. Epub 2012 Dec 5. — View Citation
Wiberg N, Kallen K, Herbst A, Olofsson P. Relation between umbilical cord blood pH, base deficit, lactate, 5-minute Apgar score and development of hypoxic ischemic encephalopathy. Acta Obstet Gynecol Scand. 2010 Oct;89(10):1263-9. doi: 10.3109/00016349.2010.513426. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality | The relative frequency of deaths in each group. | From birth to the age of 18 months | |
Primary | 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. | From birth to the age of 18 months | |
Secondary | 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). | At the age of 12 months | |
Secondary | 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). | At the age of 18 months | |
Secondary | Brain Structural Alterations(MRI) | Efficacy of cord blood by assessment of the changes in brain from baseline in MRI on Day 7. | At the age of 7 days | |
Secondary | Brain Structural Alterations(MRI) | Efficacy of cord blood by assessment of the changes in brain from baseline in MRI on Day 28. | At the age of 28 days | |
Secondary | Brain Structural Alterations(MRI) | Efficacy of cord blood by assessment of the changes in brain from baseline in MRI on 12 months old. | At the age of 12 months | |
Secondary | Brain Parenchyma Alterations(MRI) | Efficacy of cord blood by assessment of the changes in brain from baseline in MRI on Day 7. | At the age of 7 Days | |
Secondary | Brain Parenchyma Alterations(MRI) | Efficacy of cord blood by assessment of the changes in brain from baseline in MRI on Day 28. | At the age of 28 days | |
Secondary | Brain Parenchyma Alterations(MRI) | Efficacy of cord blood by assessment of the changes in brain from baseline in MRI on 12 months old. | At the age of 12 months | |
Secondary | Intracranial Hemorrhage(MRI) | Efficacy of cord blood by assessment of the changes in brain from baseline in MRI on Day 7. | At the age of 7 days | |
Secondary | Intracranial Hemorrhage(MRI) | Efficacy of cord blood by assessment of the changes in brain from baseline in MRI on Day 7. | At the age of Day 28 | |
Secondary | Intracranial Hemorrhage(MRI) | Efficacy of cord blood by assessment of the changes in brain from baseline in MRI on 12 months. | At the age of 12 months | |
Secondary | 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. | In 72 hours | |
Secondary | 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. | In 72 hours | |
Secondary | 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. | In 72 hours | |
Secondary | 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. | In 72 hours | |
Secondary | 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. | From birth to the age of 28 days in each treatment period | |
Secondary | SDF-1 in Serum | Biomarkers for Oxidative Stress, Inflammation and immune response as a measure of efficacy for hypoxic ischemic encephalopathy or cerebral infarction. | At the age of 4 days | |
Secondary | SDF-1 in Serum | Biomarkers for Oxidative Stress, Inflammation and immune response as a measure of efficacy for hypoxic ischemic encephalopathy or cerebral infarction. | At the age of 14 days | |
Secondary | TNF-alpha in Serum | Biomarkers for Oxidative Stress, Inflammation and immune response as a measure of efficacy for hypoxic ischemic encephalopathy or cerebral infarction. | At the age of 4 days | |
Secondary | TNF-alpha in Serum | Biomarkers for Oxidative Stress, Inflammation and immune response as a measure of efficacy for hypoxic ischemic encephalopathy or cerebral infarction. | At the age of 14 days | |
Secondary | IL-1 in Serum | Biomarkers for Oxidative Stress, Inflammation and immune response as a measure of efficacy for hypoxic ischemic encephalopathy or cerebral infarction. | At the age of 4 days | |
Secondary | IL-1 in Serum | Biomarkers for Oxidative Stress, Inflammation and immune response as a measure of efficacy for hypoxic ischemic encephalopathy or cerebral infarction. | At the age of 14 days |
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