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

The Ability of Near Infrared Spectroscopy Monitoring During Hypothermia Treatment to Predict Brain Injury in Infants With Hypoxic Ischemic Encephalopathy

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03835039
Enrollment
101
Registered
2019-02-08
Start date
2019-01-03
Completion date
2022-01-01
Last updated
2022-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIE - Perinatal Hypoxic - Ischemic Encephalopathy

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.

Interventions

DEVICENIRS

Monitoring cerebral and perirenal perfusion using NIRS

Sponsors

Medtronic
CollaboratorINDUSTRY
Albany Medical College
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Minutes to 2 Years
Healthy volunteers
No

Inclusion criteria

* Infants with diagnosis at birth of HIE

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
MRI findings of encephalopathy6 daysMRI studies will be reviewed and assessed for markers of HIE including damage to deep grey matter structures.
Neurodevelopment at 2 years of age2 yearsBayleys developmental test will be used to categorize the infants' neurodevelopment at 2 years of age.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026