Cerebral Oxygenation and Autoregulation in Preterm Infants (Early NIRS)
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|ClinicalTrials.gov Identifier: NCT02147769|
Recruitment Status : Completed
First Posted : May 28, 2014
Last Update Posted : July 26, 2019
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|
|Study Type :||Observational|
|Actual Enrollment :||111 participants|
|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|
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.
- 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.
- 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.
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
|United States, Alabama|
|University of Alabama|
|Birmingham, Alabama, United States, 35249|
|United States, California|
|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|
|Principal Investigator:||Valerie Chock, MD||Stanford University|
|Principal Investigator:||Krisa Van Meurs, MD||Stanford University|