Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Atlantic Health System |
---|---|
Information provided by: | Atlantic Health System |
ClinicalTrials.gov Identifier: | NCT00589953 |
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 II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy 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 |
Estimated Enrollment: | 50 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
EPO###: Placebo Comparator
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.
|
EPO ###: Experimental
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. |
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.
Ages Eligible for Study: | up to 24 Hours |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Caryn Peters, RN | 973-971-5488 | caryn.peters@atlantichealth.org |
Contact: Patricia Poland, BS | 973-971-5488 | patricia.poland@atlantichealth.org |
United States, New Jersey | |
Morristown Memorial Hospital | Recruiting |
Morristown, New Jersey, United States, 07960 | |
Contact: Caryn Peters, RN 973-971-5488 caryn.peters@atlantichealth.org | |
Contact: Patricia Poland, BS 973-971-5488 patricia.poland@atlantichealth.org | |
Sub-Investigator: Ben H Lee, MD MPH MSCR | |
Sub-Investigator: Marta Rogido, MD | |
Sub-Investigator: Joanna Louie, Pharm D | |
Principal Investigator: Augusto Sola, MD |
Principal Investigator: | Augusto Sola, MD | MidAtlantic Neonatology Associates |
Responsible Party: | MidAtlantic Neonatology Associates ( Augusto Sola MD ) |
Study ID Numbers: | R06-04-004, IND 12537 |
Study First Received: | December 27, 2007 |
Last Updated: | December 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00589953 |
Health Authority: | United States: Food and Drug Administration |
Extreme Prematurity Erythropoietin Perinatal Brain Injury Intraventricular Hemorrhage |
Periventricular Leukomalacia Neurodevelopmental Outcomes Randomized Clinical Trial |
Epoetin Alfa Craniocerebral Trauma Birth Weight Cerebral Hemorrhage Wounds and Injuries Vascular Diseases Disorders of Environmental Origin Central Nervous System Diseases Infant, Premature, Diseases Trauma, Nervous System Intracranial Hemorrhages |
Ischemia Hemorrhage Brain Diseases Cerebrovascular Disorders Leukomalacia, Periventricular Body Weight Encephalomalacia Leukomalacia Infant, Newborn, Diseases Brain Injuries |
Pathologic Processes Hematinics Therapeutic Uses Hematologic Agents |
Nervous System Diseases Cardiovascular Diseases Pharmacologic Actions |