CoolCap Trial, Treatment of Perinatal Hypoxic-Ischemic Encephalopathy
NCT ID: NCT00383305
Last Updated: 2006-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
235 participants
INTERVENTIONAL
1999-07-31
2003-09-30
Brief Summary
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Detailed Description
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Within 6 hours of birth, infants will be randomized to either a non-cooled control group with rectal temperature kept at 37+/-0.5 degC or to head cooling with mild systemic hypothermia as follows. A cooling device capable of circulating cool water in a temperature-regulated manner through a cap fitted around the infant's scalp will cool the head. The core rectal temperature of the infant will be maintained at 34.5+/-0.5 degC by adjusting the cap water temperature. The infant's rectal, nasopharyngeal, scalp (fontanel), and skin (abdominal) temperatures will be continuously monitored. Also, metabolic, cardiovascular, pulmonary and coagulation laboratory measurements will be assessed at predefined time points. Cooling will be maintained for 72 hours, followed by four hours of rewarming, with the goal of raising the rectal temperature to normal body temperature by 0.5 degC per hour. The outcome measure of severe neurodevelopmental disability and survival rates at 18 months of age will be assessed by blinded, independent observers.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Cool-Cap
Eligibility Criteria
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Inclusion Criteria
* Criteria A: Infants \>= 36 weeks gestation admitted to the NICU with ONE of the following:
* Apgar score of \<= 5 at 10 minutes after birth;
* Continued need for resuscitation, including endotracheal or mask ventilation, at 10 minutes after birth;
* Acidosis defined as either umbilical cord pH or any arterial pH within 60 minutes of birth \< 7.00; or
* Base Deficit \<= -16 mmol/L in umbilical cord blood sample OR any blood sample within 60 minutes of birth (arterial or venous blood).
* Criteria B: Moderate to severe encephalopathy consisting of altered state of consciousness (as shown by lethargy, stupor, or coma) AND at least one or more of the following:
* Hypotonia;
* Abnormal reflexes, including oculomotor or pupillary abnormalities;
* An absent or weak suck;
* Clinical seizures
* Criteria C: At least 20 minutes duration of amplitude integrated EEG (aEEG/CFM) recording that shows abnormal background aEEG/CFM activity or seizures. The aEEG/CFM is to be performed from one hour of age. If subsequently an abnormal aEEG/CFM is recorded before 5.5 hours of age, the infant is then eligible for enrollment. The aEEG is not to be performed within 30 minutes of IV anticonvulsant therapy as this may cause suppression of EEG activity. In particular, high dose prophylactic anticonvulsant therapy (e.g., \>20 mg/kg phenobarbitone) is not to be given prior to performing the aEEG/CFM.
Exclusion Criteria
* Prophylactic administration of high dose anticonvulsants (e.g., \>20 mg/kg phenobarbitone). After trial entry phenobarbitone or other anticonvulsant therapy is allowed to be given as clinically indicated to treat seizures.
* Major congenital abnormalities, such as diaphragmatic hernia requiring ventilation, or congenital abnormalities suggestive of chromosomal anomaly or other syndromes that include brain dysgenesis
* Imperforate anus
* Evidence of head trauma or skull fracture causing major intracranial hemorrhage
* Infant \< 1,800 g birth weight
* Head circumference \< (mean - 2SD) for gestation if birth weight and length are \> (mean - 2SD)
* Infant "in extremis" (i.e. an infant for whom no other additional intensive management would be offered in the judgment of the attending neonatologist)
* Unavailability of essential equipment (e.g., Cool-Cap, aEEG/CFM)
* Planned concurrent participation in other experimental treatments
1 Hour
6 Hours
ALL
No
Sponsors
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Olympic Medical
INDUSTRY
Principal Investigators
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Peter D Gluckman, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Liggins Institute, University of Auckland; Auckland, New Zealand
John S. Wyatt, M.D.
Role: PRINCIPAL_INVESTIGATOR
University College London; London, UK
Alistair J Gunn, M.D., Ph.D.
Role: STUDY_DIRECTOR
Department of Physiology, University of Auckland; Auckland, New Zealand
Locations
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Arkansas Children's Hospital
Little Rock, Arkansas, United States
Children's Hospital and Research Center at Oakland
Oakland, California, United States
University of California San Diego Medical Center (Hillcrest)
San Diego, California, United States
University of California San Francisco Children's Hospital
San Francisco, California, United States
Children's Hospital of Denver
Denver, Colorado, United States
Children's Memorial Hospital / Prentice Women's Hospital
Chicago, Illinois, United States
University of Illinois at Chicago Medical Center
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Michigan Medical Center - Mott Children's Hospital
Ann Arbor, Michigan, United States
Children's Hospital and Clinics of Minneapolis
Minneapolis, Minnesota, United States
Schneider Children's Hospital
New Hyde Park, New York, United States
Children's Hospital of new York - Presbyterian (Columbia University)
New York, New York, United States
Golisano Children's Hospital at Strong
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States
Children's Hospital of Oklahoma
Oklahoma City, Oklahoma, United States
AI Dupont Children's Hospital at Thomas Jefferson University Medical Center
Philadelphia, Pennsylvania, United States
Magee Women's Hospital / Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Royal Alexandra Hospital
Edmonton, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Children's Hospital of Eastern Ontario / The Ottawa Hospital
Ottawa, Ontario, Canada
University of Auckland - National Women's Hospital
Auckland, , New Zealand
Southmead Hospital
Bristol, England, United Kingdom
St. Michael's Hospital
Bristol, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
University College Hospital
London, , United Kingdom
Countries
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References
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Gluckman PD, Wyatt JS, Azzopardi D, Ballard R, Edwards AD, Ferriero DM, Polin RA, Robertson CM, Thoresen M, Whitelaw A, Gunn AJ. Selective head cooling with mild systemic hypothermia after neonatal encephalopathy: multicentre randomised trial. Lancet. 2005 Feb 19-25;365(9460):663-70. doi: 10.1016/S0140-6736(05)17946-X.
Dutta S, Pradeep GC, Narang A. Selective head cooling after neonatal encephalopathy. Lancet. 2005 May 7-13;365(9471):1619; author reply 1619-20. doi: 10.1016/S0140-6736(05)66503-8. No abstract available.
Bello SO. Selective head cooling after neonatal encephalopathy. Lancet. 2005 May 7-13;365(9471):1619; author reply 1619-20. doi: 10.1016/S0140-6736(05)66504-X. No abstract available.
Rutherford MA, Azzopardi D, Whitelaw A, Cowan F, Renowden S, Edwards AD, Thoresen M. Mild hypothermia and the distribution of cerebral lesions in neonates with hypoxic-ischemic encephalopathy. Pediatrics. 2005 Oct;116(4):1001-6. doi: 10.1542/peds.2005-0328.
Basu SK, Salemi JL, Gunn AJ, Kaiser JR; CoolCap Study Group. Hyperglycaemia in infants with hypoxic-ischaemic encephalopathy is associated with improved outcomes after therapeutic hypothermia: a post hoc analysis of the CoolCap Study. Arch Dis Child Fetal Neonatal Ed. 2017 Jul;102(4):F299-F306. doi: 10.1136/archdischild-2016-311385. Epub 2016 Oct 31.
Basu SK, Kaiser JR, Guffey D, Minard CG, Guillet R, Gunn AJ; CoolCap Study Group. Hypoglycaemia and hyperglycaemia are associated with unfavourable outcome in infants with hypoxic ischaemic encephalopathy: a post hoc analysis of the CoolCap Study. Arch Dis Child Fetal Neonatal Ed. 2016 Mar;101(2):F149-55. doi: 10.1136/archdischild-2015-308733. Epub 2015 Aug 17.
Other Identifiers
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PMA P040025
Identifier Type: -
Identifier Source: secondary_id
HIE-0198
Identifier Type: -
Identifier Source: secondary_id
IDE G990037
Identifier Type: -
Identifier Source: org_study_id