High-dose Erythropoietin for Asphyxia and Encephalopathy



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any
Updated:1/16/2019
Start Date:January 2017
End Date:September 2022
Contact:Yvonne Wu, MD MPH
Email:wuy@ucsf.edu

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Hypoxic-ischemic encephalopathy (HIE) occurs when a baby gets reduced blood flow and oxygen
to the brain near the time of birth. This results in death or neurologic disabilities
including cerebral palsy and cognitive impairment in up to half of affected infants. This
clinical trial will determine if the drug erythropoietin (Epo) added to hypothermia (usual
therapy) will improve outcomes for infants suffering from HIE.

Neonatal hypoxic-ischemic encephalopathy (HIE) refers to brain injury resulting from reduced
blood and oxygen flow to a baby's brain near the time of birth. HIE affects up to 12,000
newborns each year in the U.S. Half of affected infants have a bad outcome including death,
cerebral palsy and cognitive impairment despite receiving hypothermia, the only available
treatment. Erythropoietin (Epo) is a cytokine with remarkable neuroprotective and
neuroregenerative effects demonstrated in animal models of neonatal brain injury. In a phase
I trial of Epo + hypothermia, the investigators found that Epo 1000 U/Kg/dose best reproduced
the pharmacokinetics of neuroprotective dosing in animal models. Long term outcomes were
better than expected based on entry criteria and MRI findings. A phase II trial compared 50
cooled infants randomized to receive Epo or placebo. Infants treated with hypothermia + Epo
had less brain injury on early MRI, and better 12-month motor development. The investigators
hypothesize that Epo given to cooled infants with moderate/severe HIE will reduce the
combined primary outcome of death or neurodevelopmental impairment from 49 to 33%. This is a
randomized, double-blind, placebo-controlled trial of Epo therapy in 500 infants with HIE
undergoing hypothermia. Specific aims are 1) To determine if 5 doses of Epo 1000 U/kg IV
reduces the rate of death, motor or cognitive deficits at 2 years; 2) To assess safety of Epo
by evaluating clinical toxicity; and 3) To determine whether Epo decreases the severity of
neonatal brain injury as evidenced by early MRI and circulating biomarkers of brain injury.
The investigators anticipate that Epo will confer improved 2-year neurodevelopmental outcome,
will be safe, and will decrease brain injury severity as determined by early biomarkers.

Inclusion Criteria:

- ≥ 36 weeks of gestational age

- Receiving active or passive whole body cooling/hypothermia since < 6 hours of age

- Perinatal depression based on at least one of the following:

1. Apgar score < 5 at 10 minutes, or

2. Need for resuscitation at 10 minutes (i.e., chest compressions, or positive
pressure respiratory support including endotracheal, mask ventilation, or CPAP),
or

3. pH < 7.00 in cord gas (arterial or venous) or in an infant gas (arterial or
venous) obtained at < 60 minutes of age, or

4. Base deficit ≥ 15 mmol/L in cord gas (arterial or venous) or in an infant gas
(arterial or venous) obtained at < 60 minutes of age

- Moderate to severe encephalopathy (based on modified Sarnat exam) present between 1-6
hours after birth

Exclusion Criteria:

- Study drug unlikely to be administered within 26 hours of birth

- Infant has living twin (or higher order multiple) who is also being cooled

- Birth weight < 1800 g (e.g., intrauterine growth restriction)

- Genetic or congenital condition that affects neurodevelopment or requires multiple
surgeries (e.g., congenital viral infection, hydrops, complex congenital heart
disease, severe dysmorphic features, etc.)

- Head circumference < 30 cm

- Redirection of care is being considered due to moribund condition

- Patient anticipated to be unavailable for evaluation at age 2

- Polycythemia (hematocrit > 65.0%)

- Parents/legal guardians with diminished capacity and autonomy

- Infant is participating or intends to participate in another interventional study
during the birth hospitalization (note: does not include observational studies)

- Sentinel event and encephalopathy occurred only after birth

- Unable to consent in primary language of parent(s)
We found this trial at
24
sites
San Francisco, California 94143
Principal Investigator: Fernando Gonzalez, MD
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: Brenda Poindexter, MD MS
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Nathalie Maitre, MD
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Columbus, OH
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Greg Sokol, MD
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Principal Investigator: Tai-Wei Wu, MD
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: John Flibotte, MD
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Principal Investigator: Toby Yanowitz, MD
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Mariana Baserga, MD MSCI
University of Utah Research is a major component in the life of the U benefiting...
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Cincinnati, Ohio 45220
Principal Investigator: Brenda Poindexter, MD MS
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Dallas, Texas 75390
Principal Investigator: Lina Chalak, MD
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Fort Worth, Texas 76104
Principal Investigator: David Riley, MD
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2525 Chicago Ave
Minneapolis, Minnesota 55404
(612) 813-6000
Principal Investigator: Andrea Lampland, MD
Children's Hospitals and Clinics of Minnesota - Minneapolis Children's Hospitals and Clinics of Minnesota is...
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2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Principal Investigator: Hendrik Weitkamp, MD
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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Palo Alto, California 94304
Principal Investigator: Krisa Van Meurs, MD
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300 Halket St.
Pittsburgh, Pennsylvania 15213
1-866-MyMagee (696-2433)
Principal Investigator: Toby Yanowitz, MD
Magee-Womens Hospital of UPMC Magee-Womens Hospital of UPMC is a world-class center for both women's...
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Saint Louis, Missouri 63110
Principal Investigator: Amit Mathur, MD
Phone: 314-454-4031
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345 Smith Avenue North
Saint Paul, Minnesota 55102
Principal Investigator: Andrea Lampland, MD
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Salt Lake City, Utah 84157
Principal Investigator: Mariana Baserga, MD MSCI
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Salt Lake City, Utah 84143
Principal Investigator: Mariana Baserga, MD MSCI
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San antonio, Texas 78229
Principal Investigator: Kaashif Ahmad, MD
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San Antonio, Texas 78207
Principal Investigator: Kaashif Ahmad, MD
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Principal Investigator: Dennis Mayock, MD
Phone: 206-543-5257
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
Principal Investigator: Dennis Mayock, MD
Phone: 206-543-5257
University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Principal Investigator: Taeun Chang, MD
Phone: 202-259-0170
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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