High-Dose Erythropoietin in Extremely Premature Infants to Prevent/Attenuate Brain Injury: A Phase II Study
Primary Purpose
Infant, Premature, Erythropoietin, Brain Injury
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Erythropoietin
Saline placebo
Sponsored by
About this trial
This is an interventional prevention trial for Infant, Premature focused on measuring Extreme Prematurity, Erythropoietin, Perinatal Brain Injury, Intraventricular Hemorrhage, Periventricular Leukomalacia, Neurodevelopmental Outcomes, Randomized Clinical Trial
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
Sites / Locations
- Morristown Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
EPO###
EPO ###
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Severe intraventricular hemorrhage
Polycythemia, neutropenia, thrombocytopenia, hypertension, sepsis, hemorrhage, seizure
Full Information
NCT ID
NCT00589953
First Posted
December 27, 2007
Last Updated
July 29, 2013
Sponsor
Atlantic Health System
1. Study Identification
Unique Protocol Identification Number
NCT00589953
Brief Title
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
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Terminated
Study Start Date
July 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atlantic Health System
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EPO###
Arm Type
Placebo Comparator
Arm Description
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).
Arm Title
EPO ###
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Erythropoietin
Other Intervention Name(s)
Confidential Randomization Number
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Saline placebo
Other Intervention Name(s)
Confidential Randomization Number
Intervention Description
Saline vehicle at a volume of 1 mL given over 1 hour intravenously once a day for the first seven days of life.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Severe intraventricular hemorrhage
Time Frame
First ten days of life
Title
Polycythemia, neutropenia, thrombocytopenia, hypertension, sepsis, hemorrhage, seizure
Time Frame
NICU hospitalization
10. Eligibility
Sex
All
Maximum Age & Unit of Time
24 Hours
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
12. IPD Sharing Statement
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High-Dose Erythropoietin in Extremely Premature Infants to Prevent/Attenuate Brain Injury: A Phase II Study
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