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The Ability of NIRS to Predict Brain Injury in Hypoxic Ischemic Encephalopathy

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ClinicalTrials.gov Identifier: NCT03835039
Recruitment Status : Recruiting
First Posted : February 8, 2019
Last Update Posted : July 10, 2020
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Albany Medical College

Study Description
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Brief Summary:
A longitudinal study evaluating the predictive ability of near infrared spectroscopy to predict brain injury in infants with hypoxic ischemic encephalopathy. Data will be analyzed at two different time periods, at discharge and again at 2 years of age.

Condition or disease Intervention/treatment
HIE - Perinatal Hypoxic - Ischemic Encephalopathy Device: NIRS

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Ability of Near Infrared Spectroscopy Monitoring During Hypothermia Treatment to Predict Brain Injury in Infants With Hypoxic Ischemic Encephalopathy
Actual Study Start Date : January 3, 2019
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : January 1, 2026
Groups and Cohorts
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Group/Cohort Intervention/treatment
HIE
Infants with a diagnosis of HIE
 Device: NIRS
Monitoring cerebral and perirenal perfusion using NIRS


Outcome Measures
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Primary Outcome Measures :
  1. MRI findings of encephalopathy [ Time Frame: 6 days ]
    MRI studies will be reviewed and assessed for markers of HIE including damage to deep grey matter structures.

  2. Neurodevelopment at 2 years of age [ Time Frame: 2 years ]
    Bayleys developmental test will be used to categorize the infants' neurodevelopment at 2 years of age.


Eligibility Criteria
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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Newborn infants with diagnosis of HIE
Criteria

Inclusion Criteria:

  • Infants with diagnosis at birth of HIE

Exclusion Criteria:

  • none
Contacts and Locations
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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): NCT03835039


Contacts
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Contact: Kate Tauber, MD 5182621784 tauberk@amc.edu

Locations
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United States, New York
Albany Medical Center Neonatal Intesive Care Unit Recruiting
Albany, New York, United States, 12208
Contact: Kate A Tauber, MD    518-262-5421    tauberk@mail.amc.edu   
Principal Investigator: Kate A Tauber, MD         
Sponsors and Collaborators
Albany Medical College
Medtronic
More Information
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Responsible Party: Albany Medical College
ClinicalTrials.gov Identifier: NCT03835039    
Other Study ID Numbers: 5120
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Brain Injuries
Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Ischemia
Hypoxia
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Signs and Symptoms, Respiratory
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain