High-dose Erythropoietin for Asphyxia and Encephalopathy

Trial ID or NCT#

NCT02811263

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

High-dose Erythropoietin for Asphyxia and Encephalopathy

Eligibility Criteria

Ages Eligible for Study: Younger than 24 Hours
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - ≥ 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:
  1. - 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)
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Investigator(s)

Courtney Wusthoff, MD
Susan R. Hintz, M.D., M.S. Epi.

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Contact

Krisa Van Meurs, MD

View on ClinicalTrials.gov