CoolCap Trial, Treatment of Perinatal Hypoxic-Ischemic Encephalopathy
Brain-Cooling for the Treatment of Perinatal Hypoxic-Ischemic Encephalopathy
3 other identifiers
interventional
235
4 countries
27
Brief Summary
This is a research study of head cooling. Its goal is to determine whether cooling babies' heads can reduce or prevent brain damage that may have resulted from temporarily reduced oxygen supply to the brain. In this study, half of the babies (selected at random) will have a special cooling cap with circulating water placed on their head for 72 hours to lower the temperature of their brain. The rest of the baby's body will be maintained at a defined temperature by a standard overhead radiant heater. The study protocol includes the taking and analysis of blood samples, performance of brain wave tests, imaging of the brain by ultrasound, and other tests as clinically indicated. Neurodevelopmental outcome will also be assessed at 18 months of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 1999
Longer than P75 for not_applicable
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 29, 2006
CompletedFirst Posted
Study publicly available on registry
October 3, 2006
CompletedOctober 3, 2006
September 1, 2006
September 29, 2006
September 29, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Combined death or severe neurodevelopmental disability in the first 18 months of life.
Secondary Outcomes (7)
Length of hospitalization during NICU course in those surviving to discharge and for whom support was not withdrawn.
Multi-organ dysfunction (3 or more organ systems) in the neonatal period.
Rate of multiple handicap in survivors (Multiple handicap will be defined as the presence of any two of the following in an infant: neuromotor disability (Level 3-5 on GMF classification), mental delay, epilepsy, cortical visual impairment, sensorineural
Bayley PDI score
Sensorineural hearing loss >= 40 dB
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Infants are assessed sequentially by criteria A, B and C listed below. Infant must meet all three criteria to be eligible for trial enrollment.
- 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.
You may not qualify if:
- Infant expected to be \> 5.5 hours of age at the time of randomization
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Olympic Medicallead
Study Sites (27)
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Children's Hospital and Research Center at Oakland
Oakland, California, 94609, United States
University of California San Diego Medical Center (Hillcrest)
San Diego, California, 92103, United States
University of California San Francisco Children's Hospital
San Francisco, California, 94110, United States
Children's Hospital of Denver
Denver, Colorado, 80262, United States
Children's Memorial Hospital / Prentice Women's Hospital
Chicago, Illinois, 60611, United States
University of Illinois at Chicago Medical Center
Chicago, Illinois, 60612, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
University of Michigan Medical Center - Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
Children's Hospital and Clinics of Minneapolis
Minneapolis, Minnesota, 55404, United States
Schneider Children's Hospital
New Hyde Park, New York, 11040, United States
Children's Hospital of new York - Presbyterian (Columbia University)
New York, New York, 10032, United States
Golisano Children's Hospital at Strong
Rochester, New York, 14642, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Children's Hospital of Oklahoma
Oklahoma City, Oklahoma, 73190, United States
AI Dupont Children's Hospital at Thomas Jefferson University Medical Center
Philadelphia, Pennsylvania, 19107, United States
Magee Women's Hospital / Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
Children's Hospital of Eastern Ontario / The Ottawa Hospital
Ottawa, Ontario, K1H 8L1, Canada
University of Auckland - National Women's Hospital
Auckland, New Zealand
Southmead Hospital
Bristol, England, BS10 5NB, United Kingdom
St. Michael's Hospital
Bristol, BS2 8EG, United Kingdom
Hammersmith Hospital
London, W12 0NN, United Kingdom
University College Hospital
London, WC1E 6JJ, United Kingdom
Related Publications (6)
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.
PMID: 15721471RESULTDutta 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.
PMID: 15885292RESULTBello 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.
PMID: 15885291RESULTRutherford 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.
PMID: 16199715RESULTBasu 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.
PMID: 27799322DERIVEDBasu 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.
PMID: 26283669DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter D Gluckman, M.D.
The Liggins Institute, University of Auckland; Auckland, New Zealand
- PRINCIPAL INVESTIGATOR
John S. Wyatt, M.D.
University College London; London, UK
- STUDY DIRECTOR
Alistair J Gunn, M.D., Ph.D.
Department of Physiology, University of Auckland; Auckland, New Zealand
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 29, 2006
First Posted
October 3, 2006
Study Start
July 1, 1999
Study Completion
September 1, 2003
Last Updated
October 3, 2006
Record last verified: 2006-09