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

Terminated

• Conditions: HIE - Perinatal Hypoxic - Ischemic Encephalopathy
• Interventions: Device: NIRS

• Registration Number: NCT03835039
• Lead Sponsor: Albany Medical College

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-03
• Study First Submitted: 2019-01-18
• Study First Submitted QC: 2019-02-07
• Study First Posted: 2019-02-08
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• Infants with diagnosis at birth of HIE

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIE	NIRS	Infants with a diagnosis of HIE

Primary Outcome Measures

Name	Time	Method
Neurodevelopment at 2 years of age	2 years	Bayleys developmental test will be used to categorize the infants' neurodevelopment at 2 years of age.
MRI findings of encephalopathy	6 days	MRI studies will be reviewed and assessed for markers of HIE including damage to deep grey matter structures.

Trial Locations

Locations (1)

Albany Medical Center Neonatal Intesive Care Unit; 🇺🇸 Albany, New York, United States