NCT03026192

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2016

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 20, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

1.6 years

First QC Date

January 18, 2017

Last Update Submit

January 18, 2019

Conditions

Patent Ductus Arteriosus

Outcome Measures

Primary Outcomes (1)

  • Change in NIRS readings

    3 days

Study Arms (2)

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

near infrared spectroscopyDEVICE

Near infrared spectroscopy will be placed on infants both with and without hsPDA

hsPDAno PDA

Eligibility Criteria

Age1 Minute - 1 Week
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • preterm infants less than 32 weeks gestation

You may not qualify if:

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

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

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 18, 2017

First Posted

January 20, 2017

Study Start

December 1, 2016

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

January 23, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)