Status:
COMPLETED
Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO)
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Thrasher Research Fund
Seattle Children's Hospital
Conditions:
Hypoxic-ischemic Encephalopathy
Neonatal Encephalopathy
Eligibility:
All Genders
30-24 years
Phase:
PHASE1
PHASE2
Brief 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) pr...
Detailed Description
This phase I/II clinical trial is designed to demonstrate: 1. The feasibility of recruiting, enrolling and following 50 patients with moderate to severe HIE at 5 sites, while meeting specified recrui...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01913340
Start Date
September 1 2013
End Date
September 1 2016
Last Update
July 13 2020
Active Locations (7)
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1
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States, 72202
2
Stanford University
Palo Alto, California, United States
3
UCSF
San Francisco, California, United States, 94143
4
Kaiser Permanente, Santa Clara
Santa Clara, California, United States