Trial record 5 of 55 for:    Periventricular Leukomalacia

High-Dose Erythropoietin in Extremely Premature Infants to Prevent/Attenuate Brain Injury: A Phase II Study

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Atlantic Health System
ClinicalTrials.gov Identifier:
NCT00589953
First received: December 27, 2007
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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

Resource links provided by NLM:


Further study details as provided by Atlantic Health System:

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) [ Time Frame: 18-22 months corrected age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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.

  Eligibility

Ages Eligible for Study:   up to 24 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00589953

Locations
United States, New Jersey
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Sponsors and Collaborators
Atlantic Health System
  More Information

Publications:

Responsible Party: Atlantic Health System
ClinicalTrials.gov Identifier: NCT00589953     History of Changes
Other Study ID Numbers: R06-04-004, IND12537
Study First Received: December 27, 2007
Last Updated: July 29, 2013
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:
Leukomalacia, Periventricular
Brain Injuries
Cerebral Hemorrhage
Hemorrhage
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Craniocerebral Trauma
Encephalomalacia
Infant, Newborn, Diseases
Infant, Premature, Diseases
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Trauma, Nervous System
Vascular Diseases
Wounds and Injuries
Epoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014