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Cerebral Oxygenation and Autoregulation in Preterm Infants (Early NIRS)

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ClinicalTrials.gov Identifier: NCT02147769
Recruitment Status : Recruiting
First Posted : May 28, 2014
Last Update Posted : May 30, 2017
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
Estimated Enrollment : 100 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
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


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 Recruiting
Birmingham, Alabama, United States, 35249
Contact: Namasivayam Ambalavanan, MD    205-934-4680    ambal@uab.edu   
Principal Investigator: Namasivayam Ambalavanan, MD         
United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Valerie Chock, MD    650-723-5711    vchock@stanford.edu   
Principal Investigator: Valerie Chock, MD         
Santa Clara Valley Medical Center Not yet recruiting
San Jose, California, United States, 95128
Contact: Dongli Song, MD    408-885-5420    Dongli.Song@hhs.sccgov.org   
Principal Investigator: Dongli Song, MD         
United States, Connecticut
Yale-New Haven Children's Hospital Recruiting
New Haven, Connecticut, United States, 06520
Contact: Richard Ehrenkranz, MD    203-688-2320    richard.ehrenkranz@yale.edu   
Principal Investigator: Richard Ehrenkranz, MD         
United States, Illinois
St. John's Children's Hospital Recruiting
Springfield, Illinois, United States, 62702
Contact: Beau Batton, MD    217-757-6428    bbatton@siumed.edu   
Principal Investigator: Beau Batton, MD         
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Leif Nelin, MD    614-722-2775    leif.nelin@nationwidechildrens.org   
Principal Investigator: Leif Nelin, MD         
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Lina Chalak, MD    214-648-3753    lina.chalak@utsouthwestern.edu   
Principal Investigator: Lina Chalak, MD         
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     History of Changes
Other Study ID Numbers: 23894
First Posted: May 28, 2014    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

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
Obstetric Labor, Premature
Hemorrhage
Cerebral Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases