- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03835039
The Ability of NIRS to Predict Brain Injury in Hypoxic Ischemic Encephalopathy
February 28, 2022 updated by: Albany Medical College
The Ability of Near Infrared Spectroscopy Monitoring During Hypothermia Treatment to Predict Brain Injury in Infants With Hypoxic Ischemic Encephalopathy
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.
Study Overview
Status
Terminated
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
101
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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Albany, New York, United States, 12208
- Albany Medical Center Neonatal Intesive Care Unit
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 minute to 2 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Newborn infants with diagnosis of HIE
Description
Inclusion Criteria:
- Infants with diagnosis at birth of HIE
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
HIE
Infants with a diagnosis of HIE
|
Monitoring cerebral and perirenal perfusion using NIRS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 days
|
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.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 3, 2019
Primary Completion (Actual)
January 1, 2022
Study Completion (Actual)
January 1, 2022
Study Registration Dates
First Submitted
January 18, 2019
First Submitted That Met QC Criteria
February 7, 2019
First Posted (Actual)
February 8, 2019
Study Record Updates
Last Update Posted (Actual)
March 15, 2022
Last Update Submitted That Met QC Criteria
February 28, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Craniocerebral Trauma
- Trauma, Nervous System
- Signs and Symptoms, Respiratory
- Hypoxia, Brain
- Brain Ischemia
- Ischemia
- Brain Injuries
- Brain Diseases
- Hypoxia
- Hypoxia-Ischemia, Brain
Other Study ID Numbers
- 5120
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIE - Perinatal Hypoxic - Ischemic Encephalopathy
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Semmelweis UniversityCompletedPerinatal Asphyxia | Hypocapnia | Hypoxic-Ischaemic EncephalopathyHungary
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Johns Hopkins UniversityUniversity of MarylandCompletedEncephalopathy, Hypoxic-IschemicUnited States
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Medical University of GrazMedical University of Vienna; University of Alberta; Poznan University of Medical... and other collaboratorsRecruitingDeath | Neurodevelopmental DisabilityAustria, Germany, Slovenia, Canada, Ireland, Italy, Poland