Phase 2
N=50
Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO)
Hypoxic-ischemic Encephalopathy · Neonatal Encephalopathy · Birth Asphyxia
Bottom Line
View on ClinicalTrials.gov: NCT01913340 ↗Enrolled (actual)
50
Serious AEs
18.0%
Results posted
Jul 2020
Primary outcome: Primary: Markers of Organ Function — 10; 6; 9; 12 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Erythropoietin (Drug); Normal saline (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Markers of Organ Function |
10; 6; 9; 12; 6; 10 | — |
| SECONDARY Alberta Infant Motor Scale (AIMS) |
53.5; 42.8 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01913340). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.