Back to resultsNeonatal Erythropoietin in Asphyxiated Term Newborns (NEAT)
Primary Purpose
Hypoxic-ischemic Encephalopathy
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
erythropoietin
Sponsored by
About this trial
This is an interventional treatment trial for Hypoxic-ischemic Encephalopathy focused on measuring birth asphyxia, neonatal encephalopathy, hypoxic-ischemic encephalopathy, neuroprotection, neonate
Eligibility Criteria
Inclusion Criteria:
- ≥ 36 weeks gestational age
- Perinatal depression (low Apgar score, need for resuscitation)
- Moderate to severe encephalopathy
Exclusion Criteria:
- Specific aEEG findings
- Intrauterine growth restriction
- Severe congenital anomaly, genetic syndrome, metabolic disorder, arthrogryposis, TORCH infection
- Microcephaly
- Infant older than 23.5 hours of age at the time of consent
- Infant judged by an attending physician to be likely to die due to the severity of illness
- Polycythemia
- Hypertension
- No in-dwelling line
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
All enrolled patients will be in this single arm, who will receive experimental drug treatment.
Outcomes
Primary Outcome Measures
Serious adverse event
Secondary Outcome Measures
Pharmacokinetic parameters
Full Information
NCT ID
NCT00719407
First Posted
July 17, 2008
Last Updated
November 7, 2012
Sponsor
University of California, San Francisco
Collaborators
Thrasher Research Fund, UCSF Benioff Children's Hospital Oakland, University of Washington, Santa Clara Valley Health & Hospital System
1. Study Identification
Unique Protocol Identification Number
NCT00719407
Brief Title
Neonatal Erythropoietin in Asphyxiated Term Newborns
Acronym
NEAT
Official Title
Neonatal Erythropoietin in Asphyxiated Term Newborns: a Phase I Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco
Collaborators
Thrasher Research Fund, UCSF Benioff Children's Hospital Oakland, University of Washington, Santa Clara Valley Health & Hospital System
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the safety and pharmacokinetics of moderate to high doses of erythropoietin in newborn infants with birth asphyxia.
Detailed Description
Newborn infants with birth asphyxia are at high risk of death or long-term neurologic disability; yet therapies for birth asphyxia are currently limited. Erythropoietin (Epo) is a FDA-approved drug that is an effective neuroprotective agent in animal models of birth asphyxia. This is a phase I dose finding multi-center trial that will test the safety and pharmacokinetics of Epo in human infants with birth asphyxia. The long-term objectives of the proposed research are to reduce mortality and to decrease the risk of long-term disabilities in infants who survive beyond the newborn period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxic-ischemic Encephalopathy
Keywords
birth asphyxia, neonatal encephalopathy, hypoxic-ischemic encephalopathy, neuroprotection, neonate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
All enrolled patients will be in this single arm, who will receive experimental drug treatment.
Intervention Type
Drug
Intervention Name(s)
erythropoietin
Other Intervention Name(s)
Procrit
Intervention Description
250 U/kg/dose x 6 doses (n=3); 500 U/kg/dose x 6 doses (n=6); 1,000 U/kg/dose x 6 doses (n=7) 2,500 U/kg/dose x 6 doses (n=8)
Primary Outcome Measure Information:
Title
Serious adverse event
Time Frame
14 days of life
Secondary Outcome Measure Information:
Title
Pharmacokinetic parameters
Time Frame
1 to 11 days of life
10. Eligibility
Sex
All
Maximum Age & Unit of Time
24 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 36 weeks gestational age
Perinatal depression (low Apgar score, need for resuscitation)
Moderate to severe encephalopathy
Exclusion Criteria:
Specific aEEG findings
Intrauterine growth restriction
Severe congenital anomaly, genetic syndrome, metabolic disorder, arthrogryposis, TORCH infection
Microcephaly
Infant older than 23.5 hours of age at the time of consent
Infant judged by an attending physician to be likely to die due to the severity of illness
Polycythemia
Hypertension
No in-dwelling line
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvonne W Wu, MD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25439577
Citation
Rogers EE, Bonifacio SL, Glass HC, Juul SE, Chang T, Mayock DE, Durand DJ, Song D, Barkovich AJ, Ballard RA, Wu YW. Erythropoietin and hypothermia for hypoxic-ischemic encephalopathy. Pediatr Neurol. 2014 Nov;51(5):657-62. doi: 10.1016/j.pediatrneurol.2014.08.010. Epub 2014 Aug 27.
Results Reference
derived
PubMed Identifier
24524452
Citation
Shankaran S. Outcomes of hypoxic-ischemic encephalopathy in neonates treated with hypothermia. Clin Perinatol. 2014 Mar;41(1):149-59. doi: 10.1016/j.clp.2013.10.008.
Results Reference
derived
PubMed Identifier
23008465
Citation
Wu YW, Bauer LA, Ballard RA, Ferriero DM, Glidden DV, Mayock DE, Chang T, Durand DJ, Song D, Bonifacio SL, Gonzalez FF, Glass HC, Juul SE. Erythropoietin for neuroprotection in neonatal encephalopathy: safety and pharmacokinetics. Pediatrics. 2012 Oct;130(4):683-91. doi: 10.1542/peds.2012-0498. Epub 2012 Sep 24.
Results Reference
derived
Learn more about this trial
Neonatal Erythropoietin in Asphyxiated Term Newborns
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