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Congenital Heart Defects and NIRS

Tissue Oxygenation in Newborns With Congenital Heart Defects

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03411512
Enrollment
65
Registered
2018-01-26
Start date
2012-12-01
Completion date
2014-05-31
Last updated
2018-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Defects, Congenital

Keywords

congenital heart defects, near-infrared spectroscopy, newborn, tissue oxygenation

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.

Interventions

None listed

Sponsors

Petja Fister, MD, PhD
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 4 Weeks
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
rSO2RSO2 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

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026