HIE - Perinatal Hypoxic - Ischemic Encephalopathy Clinical Trial
Official title:
The Ability of Near Infrared Spectroscopy Monitoring During Hypothermia Treatment to Predict Brain Injury in Infants With Hypoxic Ischemic Encephalopathy
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 |
Verified date | February 2022 |
Source | Albany Medical College |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Albany Medical Center Neonatal Intesive Care Unit | Albany | New York |
Lead Sponsor | Collaborator |
---|---|
Albany Medical College | Medtronic |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04643821 -
NVD in Hypothermic HIE Neonates
|
Early Phase 1 |