Cerebral Palsy Clinical Trial
Official title:
Effect of Early Application of Recombinant Human Erythropoietin in Premature Infants on White Matter Lesions and Neurodevelopmental Outcome
Preterm and very preterm infants are at risk of developing encephalopathy of prematurity and long-term neurodevelopmental delay. Magnetic resonance imaging (MRI) allows the characterization of specific features of encephalopathy of prematurity, including structural changes of brain white matter and gray matter. This study wants to investigate important evidence that early repeated high-dose rhEPO(5250 IU/kg) treatment improves long-term neurological outcomes in very preterm infants and without obvious adverse effects.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | June 2019 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 3 Days |
Eligibility |
Inclusion Criteria: - premature infants who admitted to the neonatal intensive care unit(NICU) Within 72 hours after birth, gestational ages younger than 32 weeks, birth weight less than 1500 gram, informed consent was obtained from the infants' parents or guardians Exclusion Criteria: - born with anemia, polycythemia, hemolysis and other hematological diseases - hypertension, - convulsions, - a genetically defined syndrome - a severe congenital malformation adversely affecting life expectancy or neurodevelopment - severe intraventricular hemorrhage - thrombosis disease - other fatal diseases or which can seriously affect the prognosis |
Country | Name | City | State |
---|---|---|---|
China | First Affiliated Hospital of Xian JiaotongUniversity | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital Xi'an Jiaotong University | Northwest Women and Children's Hospital, Second Affiliated Hospital of Xi'an Medical University, Shaanxi Provincial People's Hospital, Tang-Du Hospital, Xi'an Children's Hospital, Xi'an No.4 Hospital, Xijing Hospital |
China,
Leuchter RH, Gui L, Poncet A, Hagmann C, Lodygensky GA, Martin E, Koller B, Darqué A, Bucher HU, Hüppi PS. Association between early administration of high-dose erythropoietin in preterm infants and brain MRI abnormality at term-equivalent age. JAMA. 2014 — View Citation
Natalucci G, Latal B, Koller B, Rüegger C, Sick B, Held L, Bucher HU, Fauchère JC; Swiss EPO Neuroprotection Trial Group. Effect of Early Prophylactic High-Dose Recombinant Human Erythropoietin in Very Preterm Infants on Neurodevelopmental Outcome at 2 Ye — View Citation
O'Gorman RL, Bucher HU, Held U, Koller BM, Hüppi PS, Hagmann CF; Swiss EPO Neuroprotection Trial Group. Tract-based spatial statistics to assess the neuroprotective effect of early erythropoietin on white matter development in preterm infants. Brain. 2015 — View Citation
Song J, Sun H, Xu F, Kang W, Gao L, Guo J, Zhang Y, Xia L, Wang X, Zhu C. Recombinant human erythropoietin improves neurological outcomes in very preterm infants. Ann Neurol. 2016 Jul;80(1):24-34. doi: 10.1002/ana.24677. Epub 2016 May 11. — View Citation
Wu YW, Mathur AM, Chang T, McKinstry RC, Mulkey SB, Mayock DE, Van Meurs KP, Rogers EE, Gonzalez FF, Comstock BA, Juul SE, Msall ME, Bonifacio SL, Glass HC, Massaro AN, Dong L, Tan KW, Heagerty PJ, Ballard RA. High-Dose Erythropoietin and Hypothermia for — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neurodevelopmental outcome | To evaluate neurodevelopmental function via Bayley Scales of Infant Development, second edition (BSID-II) at 18 months corrected age and gain incidence of MDI<70(Severe) or MDI<85(Moderate). | corrected age of 18 months | |
Secondary | TBSS(Tract-based spatial statistics) | White matter disease of the preterm infant, was semiquantitatively assessed from MRI at term-equivalent age based on an established scoring method. | corrected age of 40 weeks |
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