Clinical trial NCT00589953: High-Dose Erythropoietin in Extremely Premature Infants to Prevent/Attenuate Brain Injury: A Phase II Study
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Infant, Premature
Erythropoietin
Brain Injury
Intraventricular Hemorrhage
Periventricular Leukomalacia
Neurodevelopmental Outcomes
Randomized Clinical Trial
Keywords: Extreme Prematurity
Erythropoietin
Perinatal Brain Injury
Intraventricular Hemorrhage
Periventricular Leukomalacia
Neurodevelopmental Outcomes
Randomized Clinical Trial
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
First posted: 2008-01-10
Enrollment: 22
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 18-22 months corrected age
Secondary outcomes:
measure: Severe intraventricular hemorrhage
timeFrame: First ten days of life
measure: Polycythemia, neutropenia, thrombocytopenia, hypertension, sepsis, hemorrhage, seizure
timeFrame: NICU hospitalization
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
Study officials:
References:
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