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

Conditions

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

  • United States
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center Neonatal Intesive Care Unit

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
Device: NIRS
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

Albany Medical College

Collaborators

Medtronic

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

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.

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