Infant, Newborn Clinical Trial
Official title:
Optimizing Cooling Strategies at < 6 Hours of Age for Neonatal Hypoxic-Ischemic Encephalopathy
Verified date | March 2022 |
Source | NICHD Neonatal Research Network |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 33.5°C; (2) cooling for 120 hours to 33.5°C; (3) cooling for 72 hours to 32.0°C; and (4) cooling for 120 hours to 32.0°C. The objective of this study is to evaluate whether whole-body cooling initiated at less than 6 hours of age and continued for 120 hours and/or a depth at 32.0°C in will reduce death and disability at 18-22 months corrected age.
Status | Terminated |
Enrollment | 364 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 6 Hours |
Eligibility | Inclusion Criteria: Eligibility will be determined in a stepped process: 1. 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. 2. 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. 3. 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of New Mexico | Albuquerque | New Mexico |
United States | Emory University | Atlanta | Georgia |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Cincinnati Children's Medical Center | Cincinnati | Ohio |
United States | Case Western Reserve University, Rainbow Babies and Children's Hospital | Cleveland | Ohio |
United States | Research Institute at Nationwide Children's Hospital | Columbus | Ohio |
United States | University of Texas Southwestern Medical Center at Dallas | Dallas | Texas |
United States | Wayne State University | Detroit | Michigan |
United States | Duke University | Durham | North Carolina |
United States | RTI International | Durham | North Carolina |
United States | University of Texas Health Science Center at Houston | Houston | Texas |
United States | Indiana University | Indianapolis | Indiana |
United States | University of Iowa | Iowa City | Iowa |
United States | Children's Mercy Hospital | Kansas City | Missouri |
United States | University of California - Los Angeles | Los Angeles | California |
United States | Stanford University | Palo Alto | California |
United States | Univeristy of Pennsylvania | Philadelphia | Pennsylvania |
United States | Brown University, Women & Infants Hospital of Rhode Island | Providence | Rhode Island |
United States | University of Rochester | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
NICHD Neonatal Research Network | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Research Resources (NCRR) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Severe Neonatal Brain Abnormalities | The data for this analysis have not yet been collected.
MRIs taken between 7-14 days will be examined. |
7-14 days of life | |
Primary | Death or Moderate to Severe Disability | Death includes any mortality prior to follow up at 18-22 months. Severe disability was defined by any of the following: a Bayley III cognitive score <70, a GMFCS level of 3-5, blindness or profound hearing loss (inability to understand commands despite amplification). Moderate disability was defined as a Bayley cognitive score of 70-84 and either a GMFCS level of 2, seizure disorder, or a hearing deficit requiring amplification to understand commands. | Birth to 22 months corrected age | |
Secondary | Death | Death includes any mortality prior to follow up at 18-22 months. | Birth to 22 months corrected age | |
Secondary | Level of Disability Among Survivors | Among survivors number of normal infants and infants with mild, moderate, and severe disability
Severe disability was defined by any of the following: a Bayley III cognitive score <70, a GMFCS level of 3-5, blindness or profound hearing loss (inability to understand commands despite amplification). Moderate disability was defined as a Bayley cognitive score of 70-84 and either a GMFCS level of 2, seizure disorder, or a hearing deficit requiring amplification to understand commands. Mild impairment was defined by a cognitive score 70-84, or a cognitive score = 85 and any of the following: presence of a GMFCS level 1 or 2, seizure disorder or hearing loss not requiring amplification. Normal was defined by a cognitive score = 85 in the absence of any neurosensory deficits or seizures after NICU discharge. |
Follow up at 18-22 months corrected age | |
Secondary | Withdrawal of Care | Number of infants for whom aggressive care is withdrawn | Birth through hospital discharge, average 22 days. | |
Secondary | Clinical Neonatal Seizures | Documented seizures during hospital course | Through death, discharge, or transfer | |
Secondary | Bayley Cognitive Score | Bayley Scale of Infant Development Composite Cognitive Score. The total composite score is reported, ranging from the lowest score of 55 to the highest score of 145. Lower values specify worse outcome. | Follow up at 18-22 months corrected age | |
Secondary | Cerebral Palsy | Follow up at 18-22 months corrected age | ||
Secondary | Level of Disability Among Survivors, by Level of HIE | Among survivors, number of normal infants and infants with mild, moderate and severe disability Severe disability was defined by any of the following: a Bayley III cognitive score <70, a GMFCS level of 3-5, blindness or profound hearing loss (inability to understand commands despite amplification). Moderate disability was defined as a Bayley cognitive score of 70-84 and either a GMFCS level of 2, seizure disorder, or a hearing deficit requiring amplification to understand commands. Mild impairment was defined by a cognitive score 70-84, or a cognitive score = 85 and any of the following: presence of a GMFCS level 1 or 2, seizure disorder or hearing loss not requiring amplification. Normal was defined by a cognitive score = 85 in the absence of any neurosensory deficits or seizures after NICU discharge. | Follow up at 18-22 months corrected age | |
Secondary | Visual Impairment | Visual impairment is defined as bilateral blindness with some/no useful vision | Follow up at 18-22 months corrected age | |
Secondary | Hearing Impairment | Hearing impairment is defined as hearing impairment despite amplification | Follow up at 18-22 months corrected age | |
Secondary | Multiple Disabilities | Multiple disabilities is defined as two or more of the following 5 components: disabling CP, GMFCS level 3-5, Bayley cognitive score < 70, blindness, or deafness. | Follow up at 18-22 months corrected age | |
Secondary | Multiorgan Dysfunction | The data needed for this analysis are not collected directly, and will not be analyzed as the study was terminated early and no funds available to complete this complex analysis. The data for this study will be stored at the NICHD-DASH for investigators. | Until death, discharge, or transfer |
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