Unique ID issued by UMIN | UMIN000032627 |
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Receipt number | R000037203 |
Scientific Title | Erythropoietin, Magnesium sulfate and Hypothermia for Hypoxic-Ischemic Encephalopathy |
Date of disclosure of the study information | 2018/05/18 |
Last modified on | 2018/05/17 15:00:36 |
Erythropoietin, Magnesium sulfate and Hypothermia for Hypoxic-Ischemic Encephalopathy
Erythropoietin, Magnesium sulfate and Hypothermia for Hypoxic-Ischemic Encephalopathy
Erythropoietin, Magnesium sulfate and Hypothermia for Hypoxic-Ischemic Encephalopathy
Erythropoietin, Magnesium sulfate and Hypothermia for Hypoxic-Ischemic Encephalopathy
Japan |
Neonatal hypoxic-ischemic encephalopathy
Pediatrics |
Others
NO
To determine the feasibility and safety of erythropoietin and magnesium sulfate given in conjunction with hypothermia for hypoxicischemic encephalopathy.
Safety
Serious advverse evvents
BP and HR at 0-7 days of age
Motality and morbidity at 0-7 days and 18 months of age
Neurodevelopmental outocome at 18 months of age
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Recombinant human erythropoietin 300 U/kg every other day for 2 weeks
Mugnesium sulfate 250mg/kg for 3 days
Hypothermia 33.5 degrees C for 72 hours
1 | days-old | <= |
1 | days-old | >= |
Male and Female
Inclusion criteria by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network hypothermia trial.
Exclusion criteria by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network hypothermia trial.
9
1st name | |
Middle name | |
Last name | Hiroyuki Ichiba |
Osaka City General Hospital
Department of Neonatology
2-13-22 Miyakojimahondori, Miyakojimaku, Osaka 534-0021 JAPAN
0669291221
h-ichiba@med.osaka-cu.ac.jp
1st name | |
Middle name | |
Last name | Hiroyuki Ichiba |
Osaka City General Hospital
Department of Neonatology
2-13-22 Miyakojimahondori, Miyakojimaku, Osaka 534-0021 JAPAN
0669291221
h-ichiba@med.osaka-cu.ac.jp
Osaka City General Hospital
self funding
Self funding
NO
2018 | Year | 05 | Month | 18 | Day |
Unpublished
Completed
2012 | Year | 12 | Month | 01 | Day |
2013 | Year | 01 | Month | 01 | Day |
2017 | Year | 12 | Month | 31 | Day |
2017 | Year | 12 | Month | 31 | Day |
2018 | Year | 04 | Month | 30 | Day |
2018 | Year | 05 | Month | 17 | Day |
2018 | Year | 05 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037203
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