Patent Ductus ArteriosusNCT05639309
Liver Regional Oxygen Saturation in Preterm Patent Ductus Arteriosus
An observational study of Patent Ductus Arteriosus and Circulation, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial summary
This study evaluates the usefulness of liver perfusion and oxygenation status using regional oxygen saturation (RSO2) values obtained via near-infrared spectroscopy in assessing the hemodynamical significance of patent ductus arteriosus in preterm infants. Read more about this study
- Who is it for?
- Ages Up to 4 months
- Conditions the study is for
- Patent Ductus Arteriosus, Circulation, Newborn Morbidity
- What is being tested?
- near-infrared spectroscopy based cerebral/somatic oximeter system (INVOS™ system manufactured by Medtronics)
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jan 2023to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 4 months
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants born at less than 32 weeks' gestation and/or 1,500 grams at birth, who accepts informed consent from the their legal guardians (parents) will be included. Those with major congenital anomaly or genetic abnormality who are at high risk for adverse outcome and compensated circulatory status will be excluded.
Who may be able to join
- Gestational age at birth less than 32 weeks
- Birthweight less than 1,500 grams
Who cannot join
- Major congenital anomaly
- chromosomal / genetic anomaly
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Evaluate the Usefulness of Liver Regional Oxygen Saturation (RSO2) in Preterm Patent Ductus Arteriosus
This study evaluates the usefulness of liver perfusion and oxygenation status using regional oxygen saturation (RSO2) values obtained via near-infrared spectroscopy in assessing the hemodynamical significance of patent ductus arteriosus in preterm infants.
Read the detailed description
The usefulness of cerebral and renal regional oxygen saturation (RSO2) values for assessing hemodynamically significant patent ductus arteriosus (hsPDA) has been described previously. Meanwhile, autoregulation of the splanchnic organs' perfusion is less developed compared to the cerebral and renal system, which makes the splanchnic bed more prone to perfusion decrease and ischemia in cases of volume depletion or poor circulation. If RSO2 is measure in the liver, the solid organ reflecting the splanchnic bed perfusion status, hsPDA may be more readily identified than when only cerebral and/or renal RSO2 is monitored.
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.
- Being tested
- near-infrared spectroscopy based cerebral/somatic oximeter system (INVOS™ system manufactured by Medtronics)
- Medical subject headings
- Ductus Arteriosus, Patent, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
near-infrared spectroscopy based cerebral/somatic oximeter system (INVOS™ system manufactured by Medtronics)Device
regional oxygen saturation measurement
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: near-infrared spectroscopy based cerebral/somatic oximeter system (INVOS™ system manufactured by Medtronics) | |
| Control (no hemodynamically significant patent ductus arteriosus) | no hsPDA based on the same echocardiographic criteria described for the Case group Receives: Device: near-infrared spectroscopy based cerebral/somatic oximeter system (INVOS™ system manufactured by Medtronics) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day 2 liver regional oxygen saturation
regional oxygen saturation of liver obtained from near-infrared spectroscopy (%)
Measured: 48 to 72 hours of birth
Day 7 liver regional oxygen saturation
regional oxygen saturation of liver obtained from near-infrared spectroscopy (%)
Measured: 7 (±2) days after birth
Day 14 liver regional oxygen saturation
regional oxygen saturation of liver obtained from near-infrared spectroscopy (%)
Measured: 14 (±3) days after birth
Secondary outcomes (1)
PDA liver regional oxygen saturation
regional oxygen saturation of liver obtained from near-infrared spectroscopy (%)
Measured: When hemodynamically significant patent ductus arteriosus is clinically suspected by the attending physician, up to 28th day of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start13 Jan 2023
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patent Ductus ArteriosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea
- Responsible party
- Principal investigator, Sook Kyung Yum, Seoul St. Mary's Hospital
- Investigators
- Sook Kyung Yum, MD, PhD, Principal investigator, Seoul St. Mary's Hospital, Catholic Univeristy of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639309
- Sponsor's protocol ID
- KC22ONSI0820
- Status last verified
- May 2025
- First submitted
- 22 Nov 2022
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Usefulness of Liver Regional Oxygen Saturation (RSO2) in Preterm Patent Ductus Arteriosus
- ClinicalTrials.gov ID
- NCT05639309
- Acronym / sponsor ID
- KC22ONSI0820
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the usefulness of liver perfusion and oxygenation status using regional oxygen saturation (RSO2) values obtained via near-infrared spectroscopy in assessing the hemodynamical significance of patent ductus arteriosus in preterm infants.
Detailed description
The usefulness of cerebral and renal regional oxygen saturation (RSO2) values for assessing hemodynamically significant patent ductus arteriosus (hsPDA) has been described previously. Meanwhile, autoregulation of the splanchnic organs' perfusion is less developed compared to the cerebral and renal system, which makes the splanchnic bed more prone to perfusion decrease and ischemia in cases of volume depletion or poor circulation. If RSO2 is measure in the liver, the solid organ reflecting the splanchnic bed perfusion status, hsPDA may be more readily identified than when only cerebral and/or renal RSO2 is monitored.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case (hemodynamically significant patent ductus arteriosus) | – | Device: near-infrared spectroscopy based cerebral/somatic oximeter system (INVOS™ system manufactured by Medtronics)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 |
| Control (no hemodynamically significant patent ductus arteriosus) | – | Device: near-infrared spectroscopy based cerebral/somatic oximeter system (INVOS™ system manufactured by Medtronics)no hsPDA based on the same echocardiographic criteria described for the Case group |
Who may qualify
- Ages
- Up to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants born at less than 32 weeks' gestation and/or 1,500 grams at birth, who accepts informed consent from the their legal guardians (parents) will be included. Those with major congenital anomaly or genetic abnormality who are at high risk for adverse outcome and compensated circulatory status will be excluded.
Key inclusion criteria (2 listed)
- Gestational age at birth less than 32 weeks
- Birthweight less than 1,500 grams
Key exclusion criteria (2 listed)
- Major congenital anomaly
- chromosomal / genetic anomaly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| near-infrared spectroscopy based cerebral/somatic oximeter system (INVOS™ system manufactured by Medtronics)regional oxygen saturation measurement | Device | Case (hemodynamically significant patent ductus arteriosus), Control (no hemodynamically significant patent ductus arteriosus) |
Primary outcome
Day 2 liver regional oxygen saturation
Time frame: 48 to 72 hours of birth
regional oxygen saturation of liver obtained from near-infrared spectroscopy (%)
Day 7 liver regional oxygen saturation
Time frame: 7 (±2) days after birth
regional oxygen saturation of liver obtained from near-infrared spectroscopy (%)
Day 14 liver regional oxygen saturation
Time frame: 14 (±3) days after birth
regional oxygen saturation of liver obtained from near-infrared spectroscopy (%)
1 secondary outcome
PDA liver regional oxygen saturation
Time frame: When hemodynamically significant patent ductus arteriosus is clinically suspected by the attending physician, up to 28th day of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sook Kyung Yum, MD, PhD principal investigator
Seoul St. Mary's Hospital, Catholic Univeristy of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patent Ductus Arteriosus and Circulation, run by Seoul St. Mary's Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day 2 liver regional oxygen saturation (time frame: 48 to 72 hours of birth). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.