Premature Infant Clinical Trial
Official title:
Erythropoietin in Premature Infants to Prevent Encephalopathy: A Multi-Centre Randomized Blinded Controlled Study of the Efficacy of Erythropoietin 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 |
The main goal of this trial is to investigate whether early administration of human erythropoietin (EPO) in preterm infants improves neurodevelopmental outcome at 18 months corrected age. This study is designed as randomized, double-masked, placebo controlled multicenter study involving at least 312 patients.
Status | Terminated |
Enrollment | 58 |
Est. completion date | December 30, 2016 |
Est. primary completion date | December 30, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 48 Hours |
Eligibility | Inclusion Criteria: 1. Birthweight less or equal 1500 grams 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: 1. Intrauterine Growth Retardation 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 |
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, Maternal and Child Health Hospital of Hubei Province, Second Affiliated Hospital of Wenzhou Medical University, The Maternal & Children Health Hospital of Dehong, Yunnan of China, Xiamen Children's Hospital, Fujian of China |
China,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neurodevelopment(Bayley Scores) | To evaluate neurodevelopmental function via Bayley Scores of Infant Development Mental Development Index (BSID) and gain incidence of MDI<70(Severe) or MDI<85(Moderate). | At corrected age of 18 months | |
Primary | Neurological Evaluation(GMFM-88 Scores) | To gain changes in standardized gross motor function using GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of sub-scales, lying & rolling, sitting, crawling & kneeling, standing, walking, running & jumping (range: 0~100 , Higher value means better gross motor function). | At corrected age of 18 months | |
Secondary | Brain Structural Alterations(MRI) | To compare changes in brain as measured by MRI in Epo treatment and control groups at 9 months. | At corrected age of 9 months | |
Secondary | Brain Structural Alterations(MRI) | To compare changes in brain as measured by MRI in Epo treatment and control groups at 18 months. | At corrected age of 18 months | |
Secondary | Intracranial Hemorrhage(MRI) | To compare changes in brain as measured by MRI in Epo treatment and control groups at 9 months. | At corrected age of 9 months | |
Secondary | Intracranial Hemorrhage(MRI) | To compare changes in brain as measured by MRI in Epo treatment and control groups at 18 months. | At corrected age of 18 months | |
Secondary | Brain Parenchyma Alterations(MRI) | To compare changes in brain as measured by MRI in Epo treatment and control groups at 9 months. | At corrected age of 9 months | |
Secondary | Brain Parenchyma Alterations(MRI) | To compare changes in brain as measured by MRI in Epo treatment and control groups at 18 months. | At corrected age of 18 months | |
Secondary | Somatosensory Evoked Potential | To compare changes in brain electrophysiology by SSEP at 36 weeks. | At corrected age of 9 months | |
Secondary | Somatosensory Evoked Potential | To compare changes in brain electrophysiology by SSEP at 18 months. | At corrected age of 18 months | |
Secondary | Visual Evoked Potential | To compare changes in brain electrophysiology by VEP at 36 weeks. | At corrected age of 9 months | |
Secondary | Visual Evoked Potential | To compare changes in brain electrophysiology by VEP at 18 months. | At corrected age of 18 months | |
Secondary | Brain Stem Auditory Evoked Potential | To compare changes in brain electrophysiology by BAER at 36 weeks. | At corrected age of 9 months | |
Secondary | Brain Stem Auditory Evoked Potential | To compare changes in brain electrophysiology by BAER at 18 months. | At corrected age of 18 months | |
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. | During treament period (in 34 weeks) | |
Secondary | SDF-1 in Serum | Biomarkers for Oxidative Stress, Inflammation and immune response as a measure of efficacy of erythropoietin for hypoxic ischemic encephalopathy. | At 34 weeks | |
Secondary | TNF-alpha in Serum | Biomarkers for Oxidative Stress, Inflammation and immune response as a measure of efficacy of erythropoietin for hypoxic ischemic encephalopathy. | At 34 weeks | |
Secondary | IL-1 in Serum | Biomarkers for Oxidative Stress, Inflammation and immune response as a measure of efficacy of erythropoietin for hypoxic ischemic encephalopathy. | At 34 weeks |
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