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| Sponsor: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Collaborator: |
National Center for Research Resources (NCRR) |
| Information provided by (Responsible Party): | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00005772 |
Purpose
This large multicenter trial tested whether cerebral cooling initiated within 6 hours of birth and continued for 72 hours would reduce the risk of death and moderate to severe neurodevelopmental injury at 18-22 months corrected age. Infants at least 36 weeks gestation with an abnormal blood gas within 1 hour of birth, or a history of an acute perinatal event and a 10-min Apgar score <5, or continued need for ventilation were screened. Following a neurological exam, those with moderate to severe encephalopathy were randomized to a 72-hour period of total body cooling (cooling blanket, followed by slow re-warming). The study was conducted in two phases: Phase I (20 infants) were examined for the safety of an esophageal temperature of 34-35 C; Phase II (main trial, 200 infants) were evaluated for the safety and efficacy of an esophageal temperature of 33-34 C. Cardio-respiratory, electroencephalograms (EEGs), renal, metabolic, and hematologic status, and esophageal and abdominal skin temperature were monitored during the 72 hours of intervention. Surviving children were given neurodevelopmental examinations at 18-22 months corrected age and again at school age (6-7 years of age).
| Condition | Intervention | Phase |
|---|---|---|
|
Infant, Newborn Hypoxia-Ischemia, Brain |
Device: Induced hypothermia Device: Control |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Controlled Trial of Hypothermia for Hypoxic-Ischemic Encephalopathy in Term Infants |
| Enrollment: | 208 |
| Study Start Date: | October 1999 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | May 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Hypothermia
Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
|
Device: Induced hypothermia
Whole-body cooling using the Blanketrol II or III Units in the Automatic Control Mode with a YSI 400 series temperature probe placed in the distal esophagus over a 96-hour period
|
|
Placebo Comparator: Normothermic
Placebo: Normothermic control group (with esophageal temperature at or near 37.0°C) for 96 hours
|
Device: Control
Control group: standard care
|
Perinatal cerebral hypoxia-ischemia injury is an important cause of death and neurodevelopmental disability. Data from animal models suggest that brain cooling immediately after injury is neuroprotective. Experience with total body cooling during surgery, accidental near drownings, and one Phase I trial of term infants suggest that it is effective and safe in children.
This large multicenter trial tested whether cerebral cooling initiated within 6 hours of birth and continued for 72 hours would reduce the risk of death and moderate to severe neurodevelopmental injury at 18-22 months corrected age. Infants at least 36 weeks gestation with an abnormal blood gas within 1 hour of birth, or a history of an acute perinatal event and a 10-min Apgar score <5, or continued need for ventilation were screened. Following a neurological exam, those with moderate to severe encephalopathy were randomized to a 72-hour period of total body cooling (cooling blanket, followed by slow re-warming). The study was conducted in two phases: Phase I (20 infants) were examined for the safety of an esophageal temperature of 34-35 C; Phase II (main trial, 200 infants) were evaluated for the safety and efficacy of an esophageal temperature of 33-34 C. Cardio-respiratory, electroencephalograms (EEGs), renal, metabolic, and hematologic status, and esophageal and abdominal skin temperature were monitored during the 72 hours of intervention.
Neurodevelopmental outcome was assessed at 18-22 mos of age by masked certified examiners. The outcome at 18-22 months showed that whole-body cooling reduces the risk of death or moderate to severe disability in infants with hypoxic ischemic encephalopathy.
Surviving infants were assessed at 6-7 years (school age).
Eligibility| Ages Eligible for Study: | up to 6 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35233 | |
| United States, California | |
| Stanford University | |
| Palo Alto, California, United States, 94304 | |
| United States, Connecticut | |
| Yale University | |
| New Haven, Connecticut, United States, 06504 | |
| United States, Florida | |
| University of Miami | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30303 | |
| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Massachusetts | |
| Harvard University | |
| Cambridge, Massachusetts, United States, 02138 | |
| United States, Michigan | |
| Wayne State University | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Mexico | |
| University of New Mexico | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, North Carolina | |
| RTI International | |
| Durham, North Carolina, United States, 27705 | |
| United States, Ohio | |
| Cincinnati Children's Medical Center | |
| Cincinnati, Ohio, United States, 45267 | |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Rhode Island | |
| Brown University, Women & Infants Hospital of Rhode Island | |
| Providence, Rhode Island, United States, 02905 | |
| United States, Tennessee | |
| University of Tennessee | |
| Memphis, Tennessee, United States, 38163 | |
| United States, Texas | |
| University of Texas Southwestern Medical Center at Dallas | |
| Dallas, Texas, United States, 75235 | |
| University of Texas Health Science Center at Houston | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Seetha Shankaran, MD | Wayne State University |
| Principal Investigator: | Abbot R. Laptook, MD | Brown University, Womens and Infants Hospital of Rhode Island |
| Principal Investigator: | Michele C. Walsh, MD MS | Case Western Reserve University |
| Principal Investigator: | Ronald N. Goldberg, MD | Duke University |
| Principal Investigator: | Barbara J. Stoll, MD | Emory University |
| Principal Investigator: | Brenda B. Poindexter, MD MS | Indiana University |
| Principal Investigator: | Abhik Das, PhD | RTI International |
| Study Director: | Krisa P. Van Meurs, MD | Stanford University |
| Principal Investigator: | Waldemar A. Carlo, MD | University of Alabama at Birmingham |
| Principal Investigator: | Neil N. Finer, MD | University of California, San Diego |
| Principal Investigator: | Kurt Schibler, MD | Cincinnati Children's Medical Center |
| Principal Investigator: | Shahnaz Duara, MD | University of Miami |
| Principal Investigator: | Dale L. Phelps, MD | University of Rochester |
| Principal Investigator: | Pablo J. Sanchez, MD | University of Texas Southwestern Medical Center at Dallas |
| Principal Investigator: | Kathleen A. Kennedy, MD MPH | The University of Texas Health Science Center, Houston |
| Principal Investigator: | T. Michael O'Shea, MD | Wake Forest University |
| Principal Investigator: | Richard A. Ehrenkranz, MD | Yale University |
More Information
| Responsible Party: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00005772 History of Changes |
| Other Study ID Numbers: | NICHD-NRN-0021, U10HD021364, U10HD021373, U10HD021385, U10HD021397, U10HD027851, U10HD027853, U10HD027856, U10HD027871, U10HD027880, U10HD027904, U10HD034216, U10HD040461, U10HD040492, U10HD040498, U10HD040521, U10HD040689, M01RR000030, M01RR000039, M01RR000044, M01RR000070, M01RR000080, M01RR000633, M01RR000750, M01RR006022, M01RR007122, M01RR008084, M01RR016587 |
| Study First Received: | June 1, 2000 |
| Last Updated: | November 4, 2011 |
| Health Authority: | United States: Federal Government; United States: Institutional Review Board |
|
NICHD Neonatal Research Network Hypoxic-ischemic encephalopathy (HIE) Hypothermia Neonatal depression Perinatal asphyxia |
|
Brain Ischemia Hypothermia Ischemia Anoxia Hypoxia-Ischemia, Brain Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Body Temperature Changes Signs and Symptoms Pathologic Processes Signs and Symptoms, Respiratory Hypoxia, Brain |
