Status:
TERMINATED
Optimizing (Longer, Deeper) Cooling for Neonatal Hypoxic-Ischemic Encephalopathy(HIE)
Lead Sponsor:
NICHD Neonatal Research Network
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Infant, Newborn
Hypoxia, Brain
Eligibility:
All Genders
Up to 6 years
Phase:
NA
Brief Summary
The Optimizing Cooling trial will compare four whole-body cooling treatments for infants born at 36 weeks gestational age or later with hypoxic-ischemic encephalopathy: (1) cooling for 72 hours to 33....
Detailed Description
Hypoxic-ischemic encephalopathy (HIE) is a rare, but life-threatening condition characterized by brain injury due to asphyxia diagnosed at or shortly after birth. According to the World Health Organiz...
Eligibility Criteria
Inclusion
- Eligibility will be determined in a stepped process:
- All infants with a gestational age ≥ 36 weeks will be screened for study entry if they are admitted to the NICU with a diagnosis of fetal acidosis, perinatal asphyxia, neonatal depression or encephalopathy.
- Infants will be eligible if:
- They have a pH ≤ 7.0 or a base deficit ≥ 16m mEq/ L on umbilical cord or any postnatal sample within 1 hour of age.
- If, during this interval, they have a pH between 7.01 and 7.15, a base deficit is between 10 and 15.9 mEq/L, or a blood gas is not available, AND they have an acute perinatal event AND either a 10-minute Apgar score ≤ 5 or assisted ventilation initiated at birth and continued for at least 10 minutes.
- Once these criteria are met, eligible infants will have a standardized neurological examination performed by a certified physician examiner. Infants will be candidates for the study when encephalopathy or seizures are present. For this study, encephalopathy is defined as the presence of 1 or more signs in 3 of the following 6 categories:
- Level of consciousness: lethargy, stupor or coma;
- Spontaneous activity: decreased, absent;
- Posture: distal flexion, decerebrate;
- tone: hypotonia, flaccid or hypertonia, rigid;
- Primitive reflexes: a) suck, weak, absent; b) Moro, incomplete, flaccid;
- Autonomic nervous system: a) pupils: constricted, unequal, skew deviation or non reactive to light; b) heart rate: bradycardia, variable heart rate or c) respiration: periodic breathing, apnea.
- Eligible infants from multiple births will be enrolled in the same arm of the study.
Exclusion
- Inability to randomize by 6 hours of age
- Major congenital abnormality
- Major chromosomal abnormality (including Trisomy 21),
- Severe growth restriction (≤ 1800gm birth weight),
- Infant is moribund and will not receive any further aggressive treatment,
- Refusal of consent by parent
- Refusal of consent by attending neonatologist
- Infants with a core temperature \< 33.5°C for \> 1 hour at the time of screening by the research team would not be eligible for the study.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
364 Patients enrolled
Trial Details
Trial ID
NCT01192776
Start Date
September 1 2010
End Date
March 1 2016
Last Update
November 28 2025
Active Locations (19)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
University of California - Los Angeles
Los Angeles, California, United States, 90025
3
Stanford University
Palo Alto, California, United States, 94304
4
Emory University
Atlanta, Georgia, United States, 30303