High-Dose Erythropoietin in Extremely Premature Infants to Prevent/Attenuate Brain Injury: A Phase II Study
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The highest risk for perinatal brain injury occurs among extremely premature infants who weigh less than 1250 grams at birth. Such perinatal brain injury is currently irreversible, associated with neurodevelopmental disability, and without adequate treatment modalities. Research in recent years suggest in both animal and human studies that erythropoietin (Epo) may have significant neuroprotective effects. Given the historical safe medical profile of Epo when used for anemia of prematurity but the likely need for a greater dosage regimen for activation of neuroprotective pathways against neonatal brain injury, we therefore propose this phase II study of high-dose Epo in very low birth weight infants for the prevention and/or attenuation of prematurity-related cerebral hemorrhagic-ischemic injury.
Condition | Intervention | Phase |
---|---|---|
Infant, Premature Erythropoietin Brain Injury Intraventricular Hemorrhage Periventricular Leukomalacia Neurodevelopmental Outcomes Randomized Clinical Trial |
Drug: Erythropoietin Drug: Saline placebo |
Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
Official Title: | High-Dose Erythropoietin in Very Low Birth Weight Infants for the Potential Treatment of Prematurity-Related Cerebral Hemorrhagic-Ischemic Injury: A Phase II Safety/Tolerability Study |
- Neurodevelopmental evaluations at 18 to 22 months corrected age (cerebral palsy, Bayley Scores of Infant Development Mental Development Index (MDI), Psychomotor Development Index (PDI), bilateral hearing aid use, and visual impairment) [ Time Frame: 18-22 months corrected age ] [ Designated as safety issue: No ]
- Severe intraventricular hemorrhage [ Time Frame: First ten days of life ] [ Designated as safety issue: No ]
- Polycythemia, neutropenia, thrombocytopenia, hypertension, sepsis, hemorrhage, seizure [ Time Frame: NICU hospitalization ] [ Designated as safety issue: Yes ]
Enrollment: | 22 |
Study Start Date: | July 2007 |
Study Completion Date: | September 2010 |
Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Placebo Comparator: EPO###
All subjects will be identified as a such by the study identifier "EPO###" where EPO designates enrollment in this study and ### is a numeric identifier (e.g. 103).
|
Drug: Saline placebo
Saline vehicle at a volume of 1 mL given over 1 hour intravenously once a day for the first seven days of life.
Other Name: Confidential Randomization Number
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Experimental: EPO ###
All subjects will be identified as a such by the study identifier "EPO###" where EPO designates enrollment in this study and ### is a numeric identifier (e.g. 103).
|
Drug: Erythropoietin
5 of first 10 subjects (Group 1): 400 units/kg/dose once daily for 7 days 5 of next 10 subjects (Group 2): 800 units/kg/dose once daily for 7 days 20 of next 30 subjects (Group 3): 1000 units/kg/dose once daily for 7 days administered i.v. over 1 hour. The volume of the study drug will be 1 mL in a 1 mL Tuberculin syringe to be administered over 1 hour. Other Name: Confidential Randomization Number
|
Detailed Description:
Eligible extremely premature infants will be enrolled in this double-blind, placebo-controlled randomized trial from the neonatal intensive care unit at Morristown Memorial Hospital (Morristown, New Jersey). Subjects will be enrolled within the first 24 hours of life and randomly assigned to receive Epo or saline vehicle placebo.
Standard NICU care will be provided to all subjects. Serial exams, CBC-d, reticulocyte counts, serum Epo levels, serial HUS, and head MRI will be collected at established time points during the study period. At 18 to 22 months corrected age, subjects will undergo a neurodevelopmental evaluation assessing for cerebral palsy, Bayley Scores of Infant Development-II (BSID-II) Mental Development Index (MDI), BSID-II Psychomotor Development Index (PDI), bilateral hearing aid use, and visual impairment.
![](https://webarchive.library.unt.edu/web/20121019031247im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | up to 24 Hours |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 500 to 1250 grams at birth
- Less than 32 weeks gestation at birth
- Less than 24 hours of life at time of enrollment
Exclusion Criteria:
- Congenital anomalies (chromosomal, CNS, cardiac, GI, pulmonary)
- Seizures within first 24 hours of life
- Severe neutropenia (ANC < 500 cells/microL) within first 24 hours of life
- Polycythemia (Hct > 65%) within first 24 hours of life
- Thrombocytopenia (platelets < 50K cells/microL) within first 24 hours of life
- Hypertension (SBP > 100mmHg) without vasopressor support within first 24 hours of life
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Publications:
Responsible Party: | Atlantic Health System |
ClinicalTrials.gov Identifier: | NCT00589953 History of Changes |
Other Study ID Numbers: | R06-04-004, IND 12537 |
Study First Received: | December 27, 2007 |
Last Updated: | June 26, 2012 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by Atlantic Health System:
Extreme Prematurity Erythropoietin Perinatal Brain Injury Intraventricular Hemorrhage |
Periventricular Leukomalacia Neurodevelopmental Outcomes Randomized Clinical Trial |
Additional relevant MeSH terms:
Hemorrhage Leukomalacia, Periventricular Cerebral Hemorrhage Brain Injuries Pathologic Processes Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Encephalomalacia Vascular Diseases Cardiovascular Diseases |
Infant, Premature, Diseases Infant, Newborn, Diseases Intracranial Hemorrhages Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries Epoetin Alfa Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on October 17, 2012