Near Infrared Spectroscopy to Determine Patent Ductus Art... | NCT03026192

Studies
Near Infrared Spectroscopy to Determine Patent Ductus Arteriosus Closure

NCT03026192

Sponsor

Albany Medical College

Status

Terminated

Last Update Posted

Jan 23, 2019Actual

Enrollment

4Actual

Phase

Not provided

Conditions

Patent Ductus Arteriosus

Interventions

near infrared spectroscopy

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

Jan 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

not enough patients enrolled in study

Expanded Access Info

Start Date

Dec 2016

Primary Completion Date

Jun 30, 2018Actual

Completion Date

Jun 30, 2018Actual

First Submitted Date

Jan 18, 2017

First Submission Date that Met QC Criteria

Jan 18, 2017

First Posted Date

Jan 20, 2017Estimated

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

Jan 18, 2019

Last Update Posted Date

Jan 23, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Using cerebral and renal near infrared spectroscopy monitoring to determine PDA closure in preterm infants after completing medical treatment for a hemodynamically significant PDA.

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

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
no PDA		These are infants who do not have a patent ductus arteriosus (PDA) as determine by echocardiography	Device: near infrared spectroscopy
hsPDA		These are infants who have a hemodynamically significant PDA (hsPDA) as determined by echocardiography	Device: near infrared spectroscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
near infrared spectroscopy	Device	Near infrared spectroscopy will be placed on infants both with and without hsPDA	hsPDA no PDA

Measure	Description	Time Frame
Change in NIRS readings		3 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

preterm infants less than 32 weeks gestation

Exclusion Criteria:

infection, congenital heart disease, syndromic anomalies, and perinatal asphyxia.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Minute

Maximum Age

1 Week

Standard Ages

Child

Study Population

Preterm infants both with and without hsPDA. They will have NIRS monitors placed to measure cerebral and renal regional tissue oxygenation. Those without a hsPDA will be monitored solely around the time of initial echocardiogram. Those with a hsPDA will be monitored around initial echocardiogram and the subsequent echocardiogram after treatment completion.

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

Condition Browse Module

MeSH Terms

ID	Term
D004374	Ductus Arteriosus, Patent

Ancestor Terms

ID	Term
D006330	Heart Defects, Congenital
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019265	Spectroscopy, Near-Infrared

Ancestor Terms

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D013057	Spectrum Analysis

Browse Leaves

Not provided

Browse Branches

Not provided