Congenital Heart Defects and NIRS
Completed
- Conditions
- Heart Defects, Congenital
- Registration Number
- NCT03411512
- Lead Sponsor
- Petja Fister, MD, PhD
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method rSO2 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Medical Centre Ljubljana
🇸🇮Ljubljana, Slovenia