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Cerebral Oxygenation and Autoregulation in Preterm Infants (Early NIRS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02147769
Recruitment Status : Completed
First Posted : May 28, 2014
Last Update Posted : July 26, 2019
Sponsor:
Collaborator:
Medtronic - MITG
Information provided by (Responsible Party):
Valerie Chock, M.D., M.S. Epi, Stanford University

Brief Summary:

Premature infants are at high risk for variations in blood pressure and oxygenation during the first few days of life. The immaturity of the premature brain may further predispose these infants to death or the development of neurologic problems. The relationship between unstable blood pressure and oxygen levels and brain injury has not been well elucidated.

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.


Condition or disease Intervention/treatment
Intraventricular Hemorrhage of Prematurity Complications of Prematurity Device: NIRS monitoring

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Study Type : Observational
Actual Enrollment : 111 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cerebral Oxygenation and Autoregulation in Preterm Infants: Association With Morbidity and Mortality
Study Start Date : May 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : March 2018

Group/Cohort Intervention/treatment
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.
Device: NIRS monitoring
All enrolled infants will undergo NIRS monitoring of cerebral oxygenation in addition to monitoring of continuous arterial blood pressure.




Primary Outcome Measures :
  1. Mortality before hospital discharge [ Time Frame: Outcome measure will be assessed at the time of subject's initial discharge from the hospital (on average by 40 weeks postmenstrual age), but at a maximum of 1 year of life. ]
    Participants will be followed for the outcome of death prior to hospital discharge.

  2. Severe central nervous system (CNS) morbidity [ Time Frame: Outcome measure will be assessed on day 10 of life. Participants will be followed for neuroradiographic evidence of CNS morbidity in the first ten days of life ]
    Routine cranial ultrasound obtained within the first ten days of life will be utilized to detect grade 3 or 4 intraventricular hemorrhage, periventricular leukomalacia, significant ventriculomegaly, or white matter abnormalities.



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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All inborn preterm infants with birth weight <=1250 grams and with an indwelling arterial catheter already in place are eligible for study enrollment if they are <24 hours old at the time of enrollment. These preterm infants are at risk for impaired cerebral autoregulation and may undergo non-invasive monitoring of cerebral oxygenation using near-infrared spectroscopy (NIRS).
Criteria

Inclusion Criteria:

  • inborn
  • birth weight <= 1250 grams
  • indwelling arterial catheter in place
  • age <24 hours old

Exclusion Criteria:

  • lethal chromosomal abnormality
  • major congenital anomaly
  • skin integrity insufficient to allow placement of NIRS sensors
  • decision to not provide full intensive care

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02147769


Locations
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United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35249
United States, California
Stanford University
Palo Alto, California, United States, 94304
Santa Clara Valley Medical Center
San Jose, California, United States, 95128
United States, Connecticut
Yale-New Haven Children's Hospital
New Haven, Connecticut, United States, 06520
United States, Illinois
St. John's Children's Hospital
Springfield, Illinois, United States, 62702
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Stanford University
Medtronic - MITG
Investigators
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Principal Investigator: Valerie Chock, MD Stanford University
Principal Investigator: Krisa Van Meurs, MD Stanford University

Publications:

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Responsible Party: Valerie Chock, M.D., M.S. Epi, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT02147769    
Other Study ID Numbers: 23894
First Posted: May 28, 2014    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Keywords provided by Valerie Chock, M.D., M.S. Epi, Stanford University:
cerebral autoregulation
preterm
near-infrared spectroscopy
Additional relevant MeSH terms:
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Premature Birth
Hemorrhage
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Pathologic Processes