Whole-Body Cooling for Birth Asphyxia in Term Infants
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| ClinicalTrials.gov Identifier: NCT00005772 |
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Recruitment Status :
Completed
First Posted : June 2, 2000
Last Update Posted : March 22, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Infant, Newborn Hypoxia-Ischemia, Brain | Device: Induced hypothermia Device: Control | Phase 3 |
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).
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 208 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Randomized Controlled Trial of Hypothermia for Hypoxic-Ischemic Encephalopathy in Term Infants |
| Study Start Date : | October 1999 |
| Actual Primary Completion Date : | May 2003 |
| Actual Study Completion Date : | July 2010 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Hypothermia
Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 96 hours
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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 |
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Placebo Comparator: Normothermic
Placebo: Normothermic control group (with esophageal temperature at or near 37.0°C) for 96 hours
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Device: Control
Control group: standard care |
- Death or moderate or severe disability [ Time Frame: 18-22 months corrected age ]
- Length of hospital stay [ Time Frame: Until discharge ]
- Frequency of multi-organ dysfunction [ Time Frame: Until discharge ]
- Withdrawal of support [ Time Frame: Until discharge ]
- Post-neonatal deaths [ Time Frame: 18-22 months corrected age ]
- Multiple disability [ Time Frame: 18-22 months corrected age ]
- Seizure disorders [ Time Frame: 18-22 months corrected age ]
- Rehospitalizations [ Time Frame: 18-22 months corrected age ]
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| Ages Eligible for Study: | up to 6 Hours (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- At least 36 weeks gestation
- Any blood gas (cord, postnatal) done within the first 60 minutes had a pH less than or equal to 7.0
- Any blood gas (cord postnatal) done within the first 60 minutes had a base deficit greater than or equal to 16 mEq/L
- All infants must have seizures or signs of moderate to severe encephalopathy before randomization
Exclusion Criteria:
- Inability to randomize by 6 hours of age
- Presence of known chromosomal anomaly or major congenital anomaly
- Severe intrauterine growth restriction (weight less than 1800g)
- All blood gases done within the first 60 minutes had a pH less than 7.15 and a base deficit less than 10 mEq/L
- Infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist
- Parents refuse consent
- Attending neonatologist refuses consent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005772
| 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 | Children's Hospital Medical Center, Cincinnati | |
| 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 |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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NICHD Neonatal Research Network Hypoxic-ischemic encephalopathy (HIE) Hypothermia Neonatal depression Perinatal asphyxia |
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Brain Ischemia Hypoxia-Ischemia, Brain Ischemia Hypoxia Pathologic Processes Signs and Symptoms, Respiratory Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Hypoxia, Brain |