Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO)

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Hypoxic-ischemic Encephalopathy, Neonatal Encephalopathy, Birth Asphyxia

In brief

Hypoxic-ischemic encephalopathy (HIE), a condition of reduced blood and oxygen flow to a baby's brain near the time of birth, may cause death or neurologic disability. Cooling therapy (hypothermia) provides some protection, but about half of affected infants still have a poor outcome. This clinical trial will determine if the drug erythropoietin, given with hypothermia, is safe to use as a treatment that may further reduce the risk of neurologic deficits after HIE.

Key facts

Study ID

NCT01913340

Run by

University of California, San Francisco

People needed

50

Starts

2013-09-01

Expected to finish

2016-09-01

Last updated by the study team

2020-07-13

Who can join

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

You may qualify if…

• Newborns ≥ 36 weeks gestation, < 23 hours of age at time of consent, must meet all 3 Inclusion Criteria to be eligible for the study:
• Perinatal depression = at least one of the following: a) Apgar ≤5 at 10 min or b) required resuscitation (endotracheal or mask ventilation, or chest compressions) at 10 min or c) pH < 7.0 or base deficit ≥15 in cord, arterial, or venous blood obtained at <60 min of age;
• Moderate to severe encephalopathy = at least 3 of 6 modified Sarnat criteria present between 1-6 h of birth: a) reduced level of consciousness; b) decreased spontaneous activity; c) hypotonia; d) decreased suck; e) decreased Moro reflex; or f) respiratory distress including periodic breathing or apnea; and
• Hypothermia = passive or active cooling begun by 6 hours of age.

You may not qualify if…

• Intrauterine growth restriction (BW <1800 g);
• Major congenital malformation; suspected genetic syndrome, metabolic disorder or TORCH infection;
• Head circumference < 2 SD for gestation;
• Infant for whom withdrawal of supportive care is being considered; or
• Anticipated inability to collect primary endpoint at 12 months of age.

Where it is running

• Arkansas Children's Hospital Research Institute — Little Rock, Arkansas, United States
• Stanford University — Palo Alto, California, United States
• UCSF — San Francisco, California, United States
• Kaiser Permanente, Santa Clara — Santa Clara, California, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Washington University — St Louis, Missouri, United States
• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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