Liver Regional Oxygen Saturation in Preterm Patent Ductus Arteriosus

Sponsor

Seoul St. Mary's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05639309

Collaborator

National Research Foundation of Korea (Other)

Enrollment

Location

33.6

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Patent Ductus Arteriosus Circulation Newborn Morbidity Premature Birth	Device: near-infrared spectroscopy based cerebral/somatic oximeter system (INVOS™ system manufactured by Medtronics)

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

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Pilot Study to Evaluate the Usefulness of Liver Regional Oxygen Saturation (RSO2) in Preterm Patent Ductus Arteriosus

Actual Study Start Date :

Jan 13, 2023

Anticipated Primary Completion Date :

Oct 31, 2025

Anticipated Study Completion Date :

Oct 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
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	Device: 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	Device: near-infrared spectroscopy based cerebral/somatic oximeter system (INVOS™ system manufactured by Medtronics) regional oxygen saturation measurement

Arm

Intervention/Treatment

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

Device: 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

Device: near-infrared spectroscopy based cerebral/somatic oximeter system (INVOS™ system manufactured by Medtronics)

regional oxygen saturation measurement

Outcome Measures

Primary Outcome Measures

Day 2 liver regional oxygen saturation [48 to 72 hours of birth]
regional oxygen saturation of liver obtained from near-infrared spectroscopy (%)
Day 7 liver regional oxygen saturation [7 (±2) days after birth]
regional oxygen saturation of liver obtained from near-infrared spectroscopy (%)
Day 14 liver regional oxygen saturation [14 (±3) days after birth]
regional oxygen saturation of liver obtained from near-infrared spectroscopy (%)

Secondary Outcome Measures

PDA liver regional oxygen saturation [When hemodynamically significant patent ductus arteriosus is clinically suspected by the attending physician, up to 28th day of life]
regional oxygen saturation of liver obtained from near-infrared spectroscopy (%)

Other Outcome Measures

Day 2 cerebral regional oxygen saturation [48 to 72 hours of birth]
regional oxygen saturation of brain obtained from near-infrared spectroscopy (%)
Day 7 cerebral regional oxygen saturation [7 (±2) days after birth]
regional oxygen saturation of brain obtained from near-infrared spectroscopy (%)
Day 14 cerebral regional oxygen saturation [14 (±3) days after birth]
regional oxygen saturation of brain obtained from near-infrared spectroscopy (%)
PDA cerebral regional oxygen saturation [When hemodynamically significant patent ductus arteriosus is clinically suspected by the attending physician, , up to 28th day of life]
regional oxygen saturation of brain obtained from near-infrared spectroscopy (%)
Day 2 renal regional oxygen saturation [48 to 72 hours of birth]
regional oxygen saturation of kidney obtained from near-infrared spectroscopy (%)
Day 7 renal regional oxygen saturation [7 (±2) days after birth]
regional oxygen saturation of kidney obtained from near-infrared spectroscopy (%)
Day 14 renal regional oxygen saturation [14 (±3) days after birth]
regional oxygen saturation of kidney obtained from near-infrared spectroscopy (%)
PDA renal regional oxygen saturation [When hemodynamically significant patent ductus arteriosus is clinically suspected by the attending physician, , up to 28th day of life]
regional oxygen saturation of kidney obtained from near-infrared spectroscopy (%)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 4 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Gestational age at birth less than 32 weeks
Birthweight less than 1,500 grams

Exclusion Criteria:

Major congenital anomaly
chromosomal / genetic anomaly

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul St. Mary's Hospital	Seoul	Seocho-Gu	Korea, Republic of	06591

Sponsors and Collaborators

Seoul St. Mary's Hospital
National Research Foundation of Korea

Investigators

Principal Investigator: Sook Kyung Yum, MD, PhD, Seoul St. Mary's Hospital, Catholic Univeristy of Korea

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sook Kyung Yum, Dr. Sook Kyung Yum, Seoul St. Mary's Hospital

ClinicalTrials.gov Identifier:

NCT05639309

Other Study ID Numbers:

KC22ONSI0820

First Posted:

Dec 6, 2022

Last Update Posted:

Jan 18, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Premature Birth

Ductus Arteriosus, Patent

Study Results

No Results Posted as of Jan 18, 2023