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California Transport Cooling Trial (CTCT)

This study is currently recruiting participants.
Verified April 2013 by Stanford University
Sponsor:
Collaborator:
Inspiration Healthcare LTD UK
Information provided by (Responsible Party):
Krisa P Van Meurs, Stanford University
ClinicalTrials.gov Identifier:
NCT01683383
First received: September 6, 2012
Last updated: April 20, 2013
Last verified: April 2013
History of Changes
  Purpose

Hypoxic ischemic encephalopathy (HIE) remains a major cause of death and severe disability despite advances in neonatal and perinatal medicine. Therapeutic hypothermia is the single most promising intervention for HIE. Reduction of brain temperature by 2° to 5°C has shown to be neuroprotective in newborn and adult animal models of brain ischemia. Therapeutic hypothermia instituted within 6 hours of birth has been shown to significantly improve survival and neurodevelopmental outcome in term newborns with HIE. Hypothermia is most effective if begun during the latent period, before the secondary energy failure. It is not known whether cooling initiated after 6 hours of age is effective.

The goal of this proposal is to test the efficacy of the cooling device in achieving the target temperatures in patients with moderate to severe HIE during transport when compared with current practices.


Condition Intervention
Hypoxic Ischemic Encephalopathy
 Device: Servo-regulated cooling device, Tecotherm Neo
Other: Standard Practice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of Therapeutic Hypothermia During Transport for Hypoxic Ischemic Encephalopathy (HIE): Device-regulated Cooling Versus Standard Practice.

Resource links provided by NLM:

MedlinePlus related topics: Hypothermia
U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Percentage of temperatures in target range [ Time Frame: Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours ] [ Designated as safety issue: No ]
    The percentage of temperatures in the target range (33°-34°C) both within and between enrolled infants after cooling initiation by the transport team.


Secondary Outcome Measures:
  • Time to target temperature [ Time Frame: Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours ] [ Designated as safety issue: No ]
    Time to the target temperature range (33°-34°C) from initiation of cooling by the transport team

  • Percentage of infants in the target range at 1 hour [ Time Frame: Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours ] [ Designated as safety issue: No ]
    Percentage of infants in target range (33°-34°C) one hour after cooling initiation by the transport team

  • Temperature ranges [ Time Frame: Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours ] [ Designated as safety issue: No ]
    Range of temperatures during transport


Other Outcome Measures:
  • Safety outcomes [ Time Frame: Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours ] [ Designated as safety issue: Yes ]
    The incidence, intervention and outcome of cardiac arrhythmia, major bleeding, altered skin integrity, pulmonary hypertension, death and other serious adverse events from the time of initiation of transport cooling to the time of completion will be monitored


Estimated Enrollment: 100
Study Start Date: September 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Practice
Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
 Other: Standard Practice
Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
Experimental: Device regulated cooling
Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
 Device: Servo-regulated cooling device, Tecotherm Neo
Subjects in Arm 2 will be placed on a cooling blanket connected to the Tecotherm Neo. Temperatures will be monitored continuously and servo-regulated using a rectal temperature probe.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 6 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Term or near-term infants with gestational age ≥35 weeks who meet institutional criteria for use of therapeutic hypothermia and in whom the decision has been made to perform cooling during transport.

Exclusion Criteria:

  • Presence of a congenital or lethal chromosomal anomaly
  • Decision to not provide full intensive care
  • Refusal to consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683383

Contacts
Contact: Krisa Van Meurs, M.D. 650-723-5711 vanmeurs@stanford.edu
Contact: Vishnu Priya P Akula, M.D. 650-723-5711 priya88@stanford.edu

Locations
United States, California
Loma Linda University Children's Hospital Recruiting
Loma Linda, California, United States, 92354
Contact: Sunhwa Kim, M.D.     909-558-7448     hwakim@llu.edu    
Contact: Rene Santiago     909-651-5950     rsantiago@llu.edu    
Principal Investigator: Sunhwa Kim, M.D.            
Sub-Investigator: Rene Santiago            
Children's Hospital Central California Recruiting
Madera, California, United States, 93636
Contact: Kajori Thusu, M.D.     559-824-8300     kthusu@childrenscentralcal.org    
Contact: Margaret Holmes     559-824-8300     mholmes@childrenscentralcal.org    
Principal Investigator: Kajori Thusu, M.D.            
Sub-Investigator: Margaret Holmes            
Kaiser Permanente Oakland/Walnut Creek Recruiting
Oakland, California, United States, 94611
Contact: Anna Morgan, M.D.         anna.c.morgan@kp.org    
Contact: Barbara Mochizuki         barbara.mochizuki@kp.org    
Principal Investigator: Anna Morgan, M.D.            
Sub-Investigator: Barbara Mochizuki            
Children's Hospital & Research Center Recruiting
Oakland, California, United States, 94609
Contact: Priscilla Joe, M.D.     510-428-3000     pjoe@mail.cho.org    
Contact: Tess Estocapio     510-428-3000     testocapio@mail.cho.org    
Principal Investigator: Priscilla Joe, M.D.            
Sub-Investigator: Tess Estocapio            
Stanford University Recruiting
Palo Alto, California, United States, 94305
Contact: Krisa Van Meurs, M.D.     650-723-5711     vanmeurs@stanford.edu    
Contact: Vishnu Priya Akula, M.D.     650-723-5711     priya88@stanford.edu    
Principal Investigator: Krisa Van Meurs, M.D.            
Sub-Investigator: Vishnu Priya Akula, M.D.            
Sutter Medical Center Recruiting
Sacramento, California, United States, 95819
Contact: Stephen Butler, M.D.     916-733-1060     haydenn@sutterhealth.org    
Contact: Patty Duncan     916-733-0918     duncanp@sutterhealth.org    
Principal Investigator: Stephen Butler, M.D.            
Sub-Investigator: Patty Duncan            
Rady Childrens Hospital Recruiting
San Diego, California, United States, 92123
Contact: Jose Honold, M.D.     858-966-5818     Jhonold@rchsd.org    
Contact: Ellen Knodel, RTT     858-576-1700 ext 3436     eknodel@rchsd.org    
Principal Investigator: Jose Honold, M.D.            
Sub-Investigator: Donna Jo Veigel            
University of California San Francisco Medical Center Recruiting
San Francisco, California, United States, 94143
Contact: Tom Shimotake, M.D.     415-476-9277     shimotake@peds.ucsf.edu    
Contact: Jamie Stubson, RN     415-353-1565     jamie.stubson@ucsfmedctr.org    
Principal Investigator: Tom Shimotake, M.D.            
Sub-Investigator: Donna Cova            
Santa Clara Valley Medical Center Recruiting
San Jose, California, United States, 95128
Contact: Glenn DeSandre, M.D.     408-885-5420     glenn.desandre@vmc.sccgov.org    
Contact: Faviola Del Real     408-885-6428     faviola.delreal@hhs.sccgov.org    
Principal Investigator: Glenn DeSandre, M.D.            
Sub-Investigator: Faviola Del Real            
Sponsors and Collaborators
Stanford University
Inspiration Healthcare LTD UK
Investigators
Principal Investigator: Krisa Van Meurs, M.D. Stanford University
  More Information

Publications:

Responsible Party: Krisa P Van Meurs, Professor of Pediatrics, Stanford University
ClinicalTrials.gov Identifier: NCT01683383     History of Changes
Other Study ID Numbers: 22993
Study First Received: September 6, 2012
Last Updated: April 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Stanford University:
Hypoxic ischemic encephalopathy
Therapeutic hypothermia
Whole body cooling
Transport cooling

Additional relevant MeSH terms:
Brain Ischemia
Ischemia
Brain Damage, Chronic
Delirium
Encephalitis
Hepatic Encephalopathy
Neurotoxicity Syndromes
Hypoxia-Ischemia, Brain
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
 Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases

ClinicalTrials.gov processed this record on May 22, 2013