Congenital Heart Defects and NIRS

January 26, 2018 updated by: Petja Fister, MD, PhD

Tissue Oxygenation in Newborns With Congenital Heart Defects

Congenital Heart Defects and NIRS

Study Overview

Status

Completed

Conditions

Detailed Description

Brain, kidney and intestinal tissue oxygenation in newborns with congenital heart defects assessed by near-infrared spectroscopy.

Study Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • University Medical Centre Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

term newborns

Description

Inclusion Criteria:

Investigators included term newborns with critical structural CHD (of different types) who required surgical or transcatheter procedure in the first year of life. CHD were diagnosed by pediatric cardiologist by clinical examination and echocardiography.

Exclusion Criteria:

The exclusion criteria were pulmonary or neurological disease, perinatal asphyxia, acute illness, prematurity and congenital abnormality other than CHD.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
CHD
Newborns with structural congenital heart defects. The exclusion criteria were pulmonary or neurological disease, perinatal asphyxia, acute illness, prematurity and congenital abnormality other than CHD.
Healthy controls
The control group comprised of healthy matched newborns without a diagnosed CHD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rSO2
Time Frame: RSO2 values were obtained after 30 minute calm down period to enable stable recordings on each channel by averaging five minutes recorded values.
regional tissue oxygenation assessed by NIRS
RSO2 values were obtained after 30 minute calm down period to enable stable recordings on each channel by averaging five minutes recorded values.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Petja Fister, MD, PhD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2012

Primary Completion (Actual)

April 30, 2014

Study Completion (Actual)

May 31, 2014

Study Registration Dates

First Submitted

January 19, 2018

First Submitted That Met QC Criteria

January 25, 2018

First Posted (Actual)

January 26, 2018

Study Record Updates

Last Update Posted (Actual)

January 30, 2018

Last Update Submitted That Met QC Criteria

January 26, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIRS CHD1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Defects, Congenital

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe