Tissue Oxygenation in Newborns With Congenital Heart Defects

Petja Fister, MD, PhD1 site in 1 country65 target enrollmentDecember 1, 2012

ConditionsHeart Defects, Congenital

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Defects, Congenital
Sponsor: Petja Fister, MD, PhD
Enrollment: 65
Locations: 1
Primary Endpoint: rSO2
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Congenital Heart Defects and NIRS

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

December 1, 2012

End Date

May 31, 2014

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Petja Fister, MD, PhD

Responsible Party

Sponsor Investigator

Principal Investigator

Petja Fister, MD, PhD

Principal Investigator, Petja Fister, MD, PhD

University Medical Centre Ljubljana

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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