Phase
Condition
Neurologic Disorders
Cerebral Palsy
Treatment
N/AClinical Study ID
Ages < 24 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- ≥ 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 positivepressure respiratory support including endotracheal, mask ventilation, or CPAP),or
- pH < 7.00 in cord gas (arterial or venous) or in an infant gas (arterial orvenous) 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 1-6hours after birth
Exclusion
Exclusion Criteria:
- 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 multiplesurgeries (e.g., congenital viral infection, hydrops, complex congenital heartdisease, 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 studyduring 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)
Study Design
Study Description
Connect with a study center
University of Arkansas
Little Rock, Arkansas
United StatesSite Not Available
UC Davis
Davis, California
United StatesSite Not Available
Children's Hospital Los Angeles
Los Angeles, California
United StatesSite Not Available
Stanford University
Palo Alto, California
United StatesSite Not Available
University of California, San Francisco
San Francisco, California 94158
United StatesSite Not Available
Children's National Medical Center
Washington, District of Columbia 20010
United StatesSite Not Available
Children's National Medical Center
Washington DC, District of Columbia 20010
United StatesSite Not Available
Children's National Medical Center
Washington, D.C., District of Columbia 20010
United StatesSite Not Available
Northwestern University
Chicago, Illinois
United StatesSite Not Available
Indiana University
Indianapolis, Indiana
United StatesSite Not Available
Johns Hopkins University
Baltimore, Maryland
United StatesSite Not Available
Children's Hospitals and Clinics of Minnesota: Minneapolis
Minneapolis, Minnesota
United StatesSite Not Available
Children's Hospitals and Clinics of Minnesota: St. Paul
Saint Paul, Minnesota
United StatesSite Not Available
Childrens Hospital and Clinics of Minnesota
St Paul, Minnesota
United StatesSite Not Available
Washington University
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University
St. Louis, Missouri 63110
United StatesSite Not Available
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio
United StatesSite Not Available
Good Samaritan Hospital
Cincinnati, Ohio
United StatesSite Not Available
Nationwide Children's Hospital
Columbus, Ohio
United StatesSite Not Available
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania
United StatesSite Not Available
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania
United StatesSite Not Available
Magee Women's Hospital of UPMC
Pittsburgh, Pennsylvania
United StatesSite Not Available
Vanderbilt University
Nashville, Tennessee
United StatesSite Not Available
UT Southwestern
Dallas, Texas
United StatesSite Not Available
Cook Children's Hospital
Fort Worth, Texas
United StatesSite Not Available
Children's Hospital of San Antonio
San Antonio, Texas
United StatesSite Not Available
Methodist Children's Hospital
San Antonio, Texas
United StatesSite Not Available
Primary Children's Hospital
Salt Lake City, Utah
United StatesSite Not Available
University of Utah
Salt Lake City, Utah
United StatesSite Not Available
Seattle Children's Hospital
Seattle, Washington 98105
United StatesSite Not Available
University of Washington Medical Center
Seattle, Washington 98195
United StatesSite Not Available
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