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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03411512 |
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Date of registration:
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19/01/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Congenital Heart Defects and NIRS
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Scientific title:
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Tissue Oxygenation in Newborns With Congenital Heart Defects |
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Date of first enrolment:
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December 1, 2012 |
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Target sample size:
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65 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03411512 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Slovenia
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Key inclusion & exclusion criteria
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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.
Age minimum:
N/A
Age maximum:
4 Weeks
Gender:
All
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Health Condition(s) or Problem(s) studied
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Heart Defects, Congenital
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Primary Outcome(s)
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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.]
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Secondary ID(s)
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NIRS CHD1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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