Erythropoietin in Premature Infants to Prevent Encephalopathy
NCT ID: NCT02550054
Last Updated: 2023-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
58 participants
INTERVENTIONAL
2015-09-08
2016-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Erythropoietin
Epo is administered 1000 U/kg, iv in 48 hours after premature birth, and at 48 hours interval for 3 doses per week. After 6 doses, Subcutaneously 3 doses per week until at corrected age of 34 weeks.
Epo
Epo is administered 1000 U/kg, iv in 48 hours after premature birth, and at 48 hours interval for 3 doses per week. After 6 doses, subcutaneously 400 U/Kg per injection and 3 doses per week until at corrected age of 34 weeks.
Normal saline
Normal saline is administered 5ml, iv at 3 to 6 hours after premature birth, and at 48 hours interval for 3 doses per week. After 6 doses, Subcutaneously 3 doses per week until at corrected age of 34 weeks.
Normal saline
Normal saline is administered 5ml, iv at 3 to 6 hours after premature birth, and at 48 hours interval for 3 doses per week. After 6 doses, Subcutaneously 3 doses per week until at corrected age of 34 weeks.
Interventions
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Epo
Epo is administered 1000 U/kg, iv in 48 hours after premature birth, and at 48 hours interval for 3 doses per week. After 6 doses, subcutaneously 400 U/Kg per injection and 3 doses per week until at corrected age of 34 weeks.
Normal saline
Normal saline is administered 5ml, iv at 3 to 6 hours after premature birth, and at 48 hours interval for 3 doses per week. After 6 doses, Subcutaneously 3 doses per week until at corrected age of 34 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Less than 32 weeks gestation at birth
3. Less than 48 hours of life at time of enrollment
4. Written informed consent of parent or guardian
Exclusion Criteria
2. Severe Congenital Anomalies adversely affecting life expectancy or neurodevelopment
3. Genetic Metabolic Diseases
4. Seizures within first 24 hours of life
5. Severe neutropenia (ANC \< 500 cells/microL) within first 24 hours of life
6. Polycythemia (Hct \> 65%) within first 24 hours of life
7. Thrombocytopenia (platelets \< 50K cells/microL) within first 24 hours of life
8. Hypertension (SBP \> 100mmHg) without vasopressor support within first 24 hours of life
9. Microcephaly
10. Grade III-IV intracranial hemorrhage
Termination
1. Required by parent or guardian;
2. Polycythemia through blood transfusion can not be relieved
3. Oliguria（\<0.5mL/kg/h for at least 24 hours）
4. Progression of azotemia
5. Pulmonary hypertension or Cardiac arrhythmia
48 Hours
ALL
No
Sponsors
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Xiamen Children's Hospital, Fujian of China
OTHER
Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
OTHER
Guangzhou Women and Children's Medical Center
OTHER
Second Affiliated Hospital of Wenzhou Medical University
OTHER
Maternal and Child Health Hospital of Hubei Province
OTHER
The Maternal & Children Health Hospital of Dehong, Yunnan of China
OTHER
Children's Hospital of Fudan University
OTHER
Responsible Party
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Principal Investigators
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Wenhao Zhou, Doctor
Role: STUDY_CHAIR
Children's Hospital of Fudan University
Locations
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Children Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Countries
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References
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Leuchter RH, Gui L, Poncet A, Hagmann C, Lodygensky GA, Martin E, Koller B, Darque A, Bucher HU, Huppi PS. Association between early administration of high-dose erythropoietin in preterm infants and brain MRI abnormality at term-equivalent age. JAMA. 2014 Aug 27;312(8):817-24. doi: 10.1001/jama.2014.9645.
Dame C, Langer J, Koller BM, Fauchere JC, Bucher HU. Urinary erythropoietin concentrations after early short-term infusion of high-dose recombinant epo for neuroprotection in preterm neonates. Neonatology. 2012;102(3):172-7. doi: 10.1159/000339283. Epub 2012 Jul 4.
Kuki I, Kawawaki H, Horino A, Inoue T, Nukui M, Okazaki S, Tomiwa K, Amo K, Togawa M, Shiomi M. [A clinical study on high-dose erythropoietin therapy for acute encephalopathy or encephalitis]. No To Hattatsu. 2015 Jan;47(1):32-6. Japanese.
Traudt CM, McPherson RJ, Bauer LA, Richards TL, Burbacher TM, McAdams RM, Juul SE. Concurrent erythropoietin and hypothermia treatment improve outcomes in a term nonhuman primate model of perinatal asphyxia. Dev Neurosci. 2013;35(6):491-503. doi: 10.1159/000355460. Epub 2013 Nov 1.
Other Identifiers
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CHFudanU_NNICU4
Identifier Type: -
Identifier Source: org_study_id
NCT02601872
Identifier Type: -
Identifier Source: nct_alias