Cerebral Oxygenation and Autoregulation in Preterm Infants
NCT ID: NCT02147769
Last Updated: 2020-04-07
Study Results
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View full resultsBasic Information
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COMPLETED
111 participants
OBSERVATIONAL
2014-05-31
2018-03-31
Brief Summary
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This study investigates the utility of near-infrared spectroscopy (NIRS), a non-invasive oxygen-measuring device, to identify preterm infants at highest risk for brain injury or death.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Preterm infants monitored with NIRS
All infants enrolled in the study will be monitored with cerebral near-infrared spectroscopy (NIRS monitoring) to measure cerebral oxygenation levels in the first 96 hours of life. Mean arterial blood pressure will simultaneously be monitored.
NIRS monitoring
All enrolled infants will undergo NIRS monitoring of cerebral oxygenation in addition to monitoring of continuous arterial blood pressure.
Interventions
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NIRS monitoring
All enrolled infants will undergo NIRS monitoring of cerebral oxygenation in addition to monitoring of continuous arterial blood pressure.
Eligibility Criteria
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Inclusion Criteria
* birth weight \<= 1250 grams
* indwelling arterial catheter in place
* age \<24 hours old
Exclusion Criteria
* major congenital anomaly
* skin integrity insufficient to allow placement of NIRS sensors
* decision to not provide full intensive care
24 Hours
ALL
No
Sponsors
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Medtronic - MITG
INDUSTRY
Stanford University
OTHER
Responsible Party
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Valerie Chock, M.D., M.S. Epi
Principle Investigator
Principal Investigators
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Krisa Van Meurs, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Valerie Chock, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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University of Alabama
Birmingham, Alabama, United States
Stanford University
Palo Alto, California, United States
Santa Clara Valley Medical Center
San Jose, California, United States
Yale-New Haven Children's Hospital
New Haven, Connecticut, United States
St. John's Children's Hospital
Springfield, Illinois, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Countries
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References
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Verhagen EA, Hummel LA, Bos AF, Kooi EM. Near-infrared spectroscopy to detect absence of cerebrovascular autoregulation in preterm infants. Clin Neurophysiol. 2014 Jan;125(1):47-52. doi: 10.1016/j.clinph.2013.07.001. Epub 2013 Aug 22.
Alderliesten T, Lemmers PM, Smarius JJ, van de Vosse RE, Baerts W, van Bel F. Cerebral oxygenation, extraction, and autoregulation in very preterm infants who develop peri-intraventricular hemorrhage. J Pediatr. 2013 Apr;162(4):698-704.e2. doi: 10.1016/j.jpeds.2012.09.038. Epub 2012 Nov 6.
Soul JS, Hammer PE, Tsuji M, Saul JP, Bassan H, Limperopoulos C, Disalvo DN, Moore M, Akins P, Ringer S, Volpe JJ, Trachtenberg F, du Plessis AJ. Fluctuating pressure-passivity is common in the cerebral circulation of sick premature infants. Pediatr Res. 2007 Apr;61(4):467-73. doi: 10.1203/pdr.0b013e31803237f6.
Wong FY, Silas R, Hew S, Samarasinghe T, Walker AM. Cerebral oxygenation is highly sensitive to blood pressure variability in sick preterm infants. PLoS One. 2012;7(8):e43165. doi: 10.1371/journal.pone.0043165. Epub 2012 Aug 14.
Caicedo A, De Smet D, Naulaers G, Ameye L, Vanderhaegen J, Lemmers P, Van Bel F, Van Huffel S. Cerebral tissue oxygenation and regional oxygen saturation can be used to study cerebral autoregulation in prematurely born infants. Pediatr Res. 2011 Jun;69(6):548-53. doi: 10.1203/PDR.0b013e3182176d85.
Wong FY, Leung TS, Austin T, Wilkinson M, Meek JH, Wyatt JS, Walker AM. Impaired autoregulation in preterm infants identified by using spatially resolved spectroscopy. Pediatrics. 2008 Mar;121(3):e604-11. doi: 10.1542/peds.2007-1487. Epub 2008 Feb 4.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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23894
Identifier Type: -
Identifier Source: org_study_id
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