High-Dose Erythropoietin in Extremely Premature Infants to Prevent/Attenuate Brain Injury: A Phase II Study
| Status: | Terminated |
|---|---|
| Conditions: | Hospital, Neurology, Neurology, Women's Studies |
| Therapuetic Areas: | Neurology, Other, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/14/2017 |
| Start Date: | July 2007 |
| End Date: | September 2010 |
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
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.
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.
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.
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.
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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