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

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03835039
• Other study ID #: 5120
• Status: Terminated
• 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
• 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

Related Conditions & MeSH terms

• Brain Diseases
• Brain Injuries
• Brain Ischemia
• HIE - Perinatal Hypoxic - Ischemic Encephalopathy
• Hypoxia
• Hypoxia-Ischemia, Brain
• Ischemia

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