California Transport Cooling Trial

NCT01683383 | Completed Results DMC

• 1 other identifier: 22993
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Hypoxic Ischemic Encephalopathy

Keywords

Hypoxic ischemic encephalopathy; Therapeutic hypothermia; Whole body cooling; Transport cooling

Outcome Measures

Primary Outcomes (1)

• Percentage of Temperatures in Target Range During Transport

  The percentage of temperatures in the target range (33°-34°C) during transport after cooling initiation by the transport team.

  Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours

Secondary Outcomes (3)

• Time to Target Temperature

  Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours

• Percentage of Participants in the Target Range at 1 Hour

  Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours

• Participants in Target Temperature Range Anytime During Transport

  Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours

Other Outcomes (1)

• Safety Outcomes

  Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours

Study Arms (2)

Control (standard practice)

ACTIVE COMPARATOR

Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.

Other: Control (standard practice)

Device (servo-regulated cooling)

EXPERIMENTAL

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: Device (servo-regulated cooling)

Interventions

Device (servo-regulated cooling) DEVICE

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.

Also known as: Tecotherm Neo

Device (servo-regulated cooling)

Control (standard practice) OTHER

Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.

Control (standard practice)

Eligibility Criteria

• Age: Up to 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Presence of a congenital or lethal chromosomal anomaly
• Decision to not provide full intensive care
• Refusal to consent

Sponsors & Collaborators

• Stanford University: lead
• Inspiration Healthcare: collaborator

Study Sites (9)

Loma Linda University Children's Hospital

Loma Linda, California, 92354, United States

Location

Children's Hospital Central California

Madera, California, 93636, United States

Location

Children's Hospital & Research Center

Oakland, California, 94609, United States

Location

Kaiser Permanente Oakland/Walnut Creek

Oakland, California, 94611, United States

Location

Stanford University

Palo Alto, California, 94305, United States

Location

Sutter Medical Center

Sacramento, California, 95819, United States

Location

Rady Childrens Hospital

San Diego, California, 92123, United States

Location

University of California San Francisco Medical Center

San Francisco, California, 94143, United States

Location

Santa Clara Valley Medical Center

San Jose, California, 95128, United States

Location

Related Publications (16)

• Gunn AJ, Gunn TR, de Haan HH, Williams CE, Gluckman PD. Dramatic neuronal rescue with prolonged selective head cooling after ischemia in fetal lambs. J Clin Invest. 1997 Jan 15;99(2):248-56. doi: 10.1172/JCI119153.

  PMID: 9005993 BACKGROUND

• Vannucci RC, Perlman JM. Interventions for perinatal hypoxic-ischemic encephalopathy. Pediatrics. 1997 Dec;100(6):1004-14. doi: 10.1542/peds.100.6.1004. No abstract available.

  PMID: 9374573 BACKGROUND

• Gluckman PD, Williams CE. When and why do brain cells die? Dev Med Child Neurol. 1992 Nov;34(11):1010-4. doi: 10.1111/j.1469-8749.1992.tb11407.x. No abstract available.

  PMID: 1358734 BACKGROUND

• Iwata O, Iwata S, Thornton JS, De Vita E, Bainbridge A, Herbert L, Scaravilli F, Peebles D, Wyatt JS, Cady EB, Robertson NJ. "Therapeutic time window" duration decreases with increasing severity of cerebral hypoxia-ischaemia under normothermia and delayed hypothermia in newborn piglets. Brain Res. 2007 Jun 18;1154:173-80. doi: 10.1016/j.brainres.2007.03.083. Epub 2007 Apr 1.

  PMID: 17475224 BACKGROUND

• 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: 15721471 BACKGROUND

• Eicher DJ, Wagner CL, Katikaneni LP, Hulsey TC, Bass WT, Kaufman DA, Horgan MJ, Languani S, Bhatia JJ, Givelichian LM, Sankaran K, Yager JY. Moderate hypothermia in neonatal encephalopathy: efficacy outcomes. Pediatr Neurol. 2005 Jan;32(1):11-7. doi: 10.1016/j.pediatrneurol.2004.06.014.

  PMID: 15607598 BACKGROUND

• Shankaran S, Laptook AR, Ehrenkranz RA, Tyson JE, McDonald SA, Donovan EF, Fanaroff AA, Poole WK, Wright LL, Higgins RD, Finer NN, Carlo WA, Duara S, Oh W, Cotten CM, Stevenson DK, Stoll BJ, Lemons JA, Guillet R, Jobe AH; National Institute of Child Health and Human Development Neonatal Research Network. Whole-body hypothermia for neonates with hypoxic-ischemic encephalopathy. N Engl J Med. 2005 Oct 13;353(15):1574-84. doi: 10.1056/NEJMcps050929.

  PMID: 16221780 BACKGROUND

• Azzopardi DV, Strohm B, Edwards AD, Dyet L, Halliday HL, Juszczak E, Kapellou O, Levene M, Marlow N, Porter E, Thoresen M, Whitelaw A, Brocklehurst P; TOBY Study Group. Moderate hypothermia to treat perinatal asphyxial encephalopathy. N Engl J Med. 2009 Oct 1;361(14):1349-58. doi: 10.1056/NEJMoa0900854.

  PMID: 19797281 BACKGROUND

• Simbruner G, Mittal RA, Rohlmann F, Muche R; neo.nEURO.network Trial Participants. Systemic hypothermia after neonatal encephalopathy: outcomes of neo.nEURO.network RCT. Pediatrics. 2010 Oct;126(4):e771-8. doi: 10.1542/peds.2009-2441. Epub 2010 Sep 20.

  PMID: 20855387 BACKGROUND

• Jacobs SE, Morley CJ, Inder TE, Stewart MJ, Smith KR, McNamara PJ, Wright IM, Kirpalani HM, Darlow BA, Doyle LW; Infant Cooling Evaluation Collaboration. Whole-body hypothermia for term and near-term newborns with hypoxic-ischemic encephalopathy: a randomized controlled trial. Arch Pediatr Adolesc Med. 2011 Aug;165(8):692-700. doi: 10.1001/archpediatrics.2011.43. Epub 2011 Apr 4.

  PMID: 21464374 BACKGROUND

• Fairchild K, Sokora D, Scott J, Zanelli S. Therapeutic hypothermia on neonatal transport: 4-year experience in a single NICU. J Perinatol. 2010 May;30(5):324-9. doi: 10.1038/jp.2009.168. Epub 2009 Oct 22.

  PMID: 19847186 BACKGROUND

• Hallberg B, Olson L, Bartocci M, Edqvist I, Blennow M. Passive induction of hypothermia during transport of asphyxiated infants: a risk of excessive cooling. Acta Paediatr. 2009 Jun;98(6):942-6. doi: 10.1111/j.1651-2227.2009.01303.x.

  PMID: 19484830 BACKGROUND

• Akula VP, Davis AS, Gould JB, Van Meurs K. Therapeutic hypothermia during neonatal transport: current practices in California. Am J Perinatol. 2012 May;29(5):319-26. doi: 10.1055/s-0031-1295661. Epub 2011 Dec 5.

  PMID: 22143969 BACKGROUND

• Kendall GS, Kapetanakis A, Ratnavel N, Azzopardi D, Robertson NJ; Cooling on Retrieval Study Group. Passive cooling for initiation of therapeutic hypothermia in neonatal encephalopathy. Arch Dis Child Fetal Neonatal Ed. 2010 Nov;95(6):F408-12. doi: 10.1136/adc.2010.187211. Epub 2010 Sep 24.

  PMID: 20870910 BACKGROUND

• Akula VP, Gould JB, Davis AS, Hackel A, Oehlert J, Van Meurs KP. Therapeutic hypothermia during neonatal transport: data from the California Perinatal Quality Care Collaborative (CPQCC) and California Perinatal Transport System (CPeTS) for 2010. J Perinatol. 2013 Mar;33(3):194-7. doi: 10.1038/jp.2012.144. Epub 2012 Dec 6.

  PMID: 23223159 BACKGROUND

• Akula VP, Joe P, Thusu K, Davis AS, Tamaresis JS, Kim S, Shimotake TK, Butler S, Honold J, Kuzniewicz M, DeSandre G, Bennett M, Gould J, Wallenstein MB, Van Meurs K. A randomized clinical trial of therapeutic hypothermia mode during transport for neonatal encephalopathy. J Pediatr. 2015 Apr;166(4):856-61.e1-2. doi: 10.1016/j.jpeds.2014.12.061. Epub 2015 Feb 12.

  PMID: 25684087 DERIVED

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

1, The criteria used to initiate hypothermia varied. 2, Operational errors occurred in 9 newborns during device regulated cooling. 3, 9.6% of temperatures in the control arm were missing.

Results Point of Contact

• Title: Krisa P. Van Meurs, M.D.
• Organization: Stanford University School of Medicine

vanmeurs@stanford.edu

+1 650 723 5711

Study Officials

• Krisa Van Meurs, M.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: September 6, 2012
• First Posted: September 11, 2012
• Study Start: September 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 8, 2014
• Results First Posted: December 8, 2014

Record last verified: 2014-12

Locations

US (9)