High-dose Erythropoietin for Asphyxia and Encephalopathy

Completed · Phase 3 · Has a placebo group

Conditions studied: Neonatal Encephalopathy, Birth Asphyxia

In brief

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.

Key facts

Study ID

NCT02811263

Run by

University of California, San Francisco

People needed

500

Starts

2017-01-01

Expected to finish

2022-04-01

Last updated by the study team

2023-01-30

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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:
• Apgar score < 5 at 10 minutes, or
• Need for resuscitation at 10 minutes (i.e., chest compressions, or positive pressure respiratory support including endotracheal, mask ventilation, or CPAP), or
• pH < 7.00 in cord gas (arterial or venous) or in an infant gas (arterial or venous) obtained at < 60 minutes of age, or
• 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

You may not qualify if…

• 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)

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States
• Stanford University — Palo Alto, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Indiana University — Indianapolis, Indiana, United States
• Children's Hospitals and Clinics of Minnesota: Minneapolis — Minneapolis, Minnesota, United States
• Children's Hospitals and Clinics of Minnesota: St. Paul — Saint Paul, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Good Samaritan Hospital — Cincinnati, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
• Magee Women's Hospital of UPMC — Pittsburgh, Pennsylvania, United States
• Vanderbilt University — Nashville, Tennessee, United States
• UT Southwestern — Dallas, Texas, United States
• Cook Children's Hospital — Fort Worth, Texas, United States
• Children's Hospital of San Antonio — San Antonio, Texas, United States
• Methodist Children's Hospital — San Antonio, Texas, United States
• Primary Children's Hospital — Salt Lake City, Utah, United States
• University of Utah — Salt Lake City, Utah, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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