Congenital Heart Defects and NIRS | Clinical Trial

Key information

Conditions

Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Diseases

Age range

1 day–4 week

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Petja Fister, MD, PhD

Other

Registry information

Official study title

Tissue Oxygenation in Newborns With Congenital Heart Defects

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Jan 26, 2018
Registry last updated: Jan 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed