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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03835039
Other study ID # 5120
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date January 3, 2019
Est. completion date January 1, 2022

Study information

Verified date February 2022
Source Albany Medical College
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 101
Est. completion date January 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Years
Eligibility Inclusion Criteria: - Infants with diagnosis at birth of HIE Exclusion Criteria: - none

Study Design


Related Conditions & MeSH terms


Intervention

Device:
NIRS
Monitoring cerebral and perirenal perfusion using NIRS

Locations

Country Name City State
United States Albany Medical Center Neonatal Intesive Care Unit Albany New York

Sponsors (2)

Lead Sponsor Collaborator
Albany Medical College Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary MRI findings of encephalopathy MRI studies will be reviewed and assessed for markers of HIE including damage to deep grey matter structures. 6 days
Primary Neurodevelopment at 2 years of age Bayleys developmental test will be used to categorize the infants' neurodevelopment at 2 years of age. 2 years
See also
  Status Clinical Trial Phase
Completed NCT04643821 - NVD in Hypothermic HIE Neonates Early Phase 1