Hypoxic Ischemic Encephalopathy Clinical Trial
— CTCTOfficial title:
A Randomized Clinical Trial of Therapeutic Hypothermia During Transport for Hypoxic Ischemic Encephalopathy (HIE): Device-regulated Cooling Versus Standard Practice.
Verified date | December 2014 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 101 |
Est. completion date | October 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 6 Hours |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Loma Linda University Children's Hospital | Loma Linda | California |
United States | Children's Hospital Central California | Madera | California |
United States | Children's Hospital & Research Center | Oakland | California |
United States | Kaiser Permanente Oakland/Walnut Creek | Oakland | California |
United States | Stanford University | Palo Alto | California |
United States | Sutter Medical Center | Sacramento | California |
United States | Rady Childrens Hospital | San Diego | California |
United States | University of California San Francisco Medical Center | San Francisco | California |
United States | Santa Clara Valley Medical Center | San Jose | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University | Inspiration Healthcare LTD UK |
United States,
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. — View Citation
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. Erratum in: N Engl J Med. 2010 Mar 18;362(11):1056. — View Citation
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. — View Citation
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. — View Citation
Gluckman PD, Williams CE. When and why do brain cells die? Dev Med Child Neurol. 1992 Nov;34(11):1010-4. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Epub 2007 Apr 1. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Van Meurs K, Akula VP, Davis AS, Gould J. Therapeutic hypothermia during neonatal transport in 2010: Data from the California Perinatal Quality Care Collaborative (CPQCC) and the California Perinatal Transport System (CPeTS). International Perinatal Collegium XXII Biennial Meeting, Amalfi, Italy, June 25-29, 2011.
Vannucci RC, Perlman JM. Interventions for perinatal hypoxic-ischemic encephalopathy. Pediatrics. 1997 Dec;100(6):1004-14. Review. — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety Outcomes | The incidence, intervention and outcome of cardiac arrhythmia, major bleeding, altered skin integrity, pulmonary hypertension, device-related events, death, and other serious adverse events from the time of initiation of transport cooling to the time of completion will be monitored. | Participants will be followed for the duration of neonatal transport from the birth hospital to the cooling center, an expected average of 4 hours | Yes |
Primary | 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 | No |
Secondary | Time to Target Temperature | Time to the target temperature range (33°-34°C) from initiation of cooling 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 | No |
Secondary | Percentage of Participants in the Target Range at 1 Hour | Percentage of participants in target range (33°-34°C) one hour 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 | No |
Secondary | Participants in Target Temperature Range Anytime During Transport | Participants in target temperature range (33-34 C) 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 | No |
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