NCT03835039

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2019

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 8, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

March 15, 2022

Status Verified

February 1, 2022

Enrollment Period

3 years

First QC Date

January 18, 2019

Last Update Submit

February 28, 2022

Conditions

HIE - Perinatal Hypoxic - Ischemic Encephalopathy

Outcome Measures

Primary Outcomes (2)

  • MRI findings of encephalopathy

    MRI studies will be reviewed and assessed for markers of HIE including damage to deep grey matter structures.

    6 days

  • Neurodevelopment at 2 years of age

    Bayleys developmental test will be used to categorize the infants' neurodevelopment at 2 years of age.

    2 years

Study Arms (1)

HIE

Infants with a diagnosis of HIE

Device: NIRS

Interventions

NIRSDEVICE

Monitoring cerebral and perirenal perfusion using NIRS

HIE

Eligibility Criteria

Age1 Minute - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Newborn infants with diagnosis of HIE

You may qualify if:

  • Infants with diagnosis at birth of HIE

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albany Medical Center Neonatal Intesive Care Unit

Albany, New York, 12208, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2019

First Posted

February 8, 2019

Study Start

January 3, 2019

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

March 15, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)