Liver Regional Oxygen Saturation in Preterm Patent Ductus Arteriosus
NCT ID: NCT05639309
Last Updated: 2025-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2023-01-13
2025-03-31
Brief Summary
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Detailed Description
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This study aims to evaluate the usefulness of liver RSO2 measurement in assessing the hemodynamical significance of patent ductus arteriosus in preterm infants, in comparison to cerebral and renal RSO2.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Case (hemodynamically significant patent ductus arteriosus)
Hemodynamically significant patent ductus arteriosus (hsPDA) diagnosed by echocardiographic criteria including pulsatile left-to-right shunt through patent ductus arteriosus, enlarged left atrium and/or left ventricle, increased left pulmonary artery velocity, absent or reversed end-diastolic flow of anterior cerebral artery and/or renal artery
near-infrared spectroscopy based cerebral/somatic oximeter system (INVOS™ system manufactured by Medtronics)
regional oxygen saturation measurement
Control (no hemodynamically significant patent ductus arteriosus)
no hsPDA based on the same echocardiographic criteria described for the Case group
near-infrared spectroscopy based cerebral/somatic oximeter system (INVOS™ system manufactured by Medtronics)
regional oxygen saturation measurement
Interventions
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near-infrared spectroscopy based cerebral/somatic oximeter system (INVOS™ system manufactured by Medtronics)
regional oxygen saturation measurement
Eligibility Criteria
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Inclusion Criteria
* Birthweight less than 1,500 grams
Exclusion Criteria
* chromosomal / genetic anomaly
4 Months
ALL
No
Sponsors
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National Research Foundation of Korea
OTHER
Seoul St. Mary's Hospital
OTHER
Responsible Party
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Sook Kyung Yum
Dr. Sook Kyung Yum
Principal Investigators
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Sook Kyung Yum, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul St. Mary's Hospital, Catholic Univeristy of Korea
Locations
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Seoul St. Mary's Hospital
Seoul, Seocho-Gu, South Korea
Countries
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Other Identifiers
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KC22ONSI0820
Identifier Type: -
Identifier Source: org_study_id
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