The Ability of NIRS to Predict Brain Injury in Hypoxic Is... | NCT03835039

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

NCT03835039

Sponsor

Albany Medical College

Status

Terminated

Last Update Posted

Mar 15, 2022Actual

Enrollment

101Actual

Phase

Not provided

Conditions

HIE - Perinatal Hypoxic - Ischemic Encephalopathy

Interventions

NIRS

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Interim analysis not showing significant results

Expanded Access Info

Start Date

Jan 3, 2019Actual

Primary Completion Date

Jan 1, 2022Actual

Completion Date

Jan 1, 2022Actual

First Submitted Date

Jan 18, 2019

First Submission Date that Met QC Criteria

Feb 7, 2019

First Posted Date

Feb 8, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2022

Last Update Posted Date

Mar 15, 2022Actual

Name	Class
Medtronic	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

101Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HIE		Infants with a diagnosis of HIE	Device: NIRS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NIRS	Device	Monitoring cerebral and perirenal perfusion using NIRS	HIE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Infants with diagnosis at birth of HIE

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Minute

Maximum Age

2 Years

Standard Ages

Child

Study Population

Newborn infants with diagnosis of HIE

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Albany Medical Center Neonatal Intesive Care Unit		Albany	New York	12208	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided