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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03411512
Other study ID # NIRS CHD1
Secondary ID
Status Completed
Phase N/A
First received January 19, 2018
Last updated January 26, 2018
Start date December 1, 2012
Est. completion date May 31, 2014

Study information

Verified date January 2018
Source University Medical Centre Ljubljana
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Congenital Heart Defects and NIRS


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date May 31, 2014
Est. primary completion date April 30, 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 4 Weeks
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
Slovenia University Medical Centre Ljubljana Ljubljana

Sponsors (1)

Lead Sponsor Collaborator
Petja Fister, MD, PhD

Country where clinical trial is conducted

Slovenia, 

Outcome

Type Measure Description Time frame Safety issue
Primary rSO2 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.
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