Liver Regional Oxygen Saturation in Preterm Patent Ductus Arteriosus

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.

Study Overview

• Status: Recruiting
• Conditions: Premature Birth; Patent Ductus Arteriosus; Circulation; Newborn Morbidity
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Sook Kyung Yum, MD, PhD; Phone Number: +82-2-2258-6993; Email: cookieyyum@gmail.com
• Study Contact Backup: Name: Yumi Seo, MD; Phone Number: +82-2-2258-6767; Email: seoyum1130@naver.com

Study Locations

• Korea, Republic of
  • Seocho-Gu
    • Seoul, Seocho-Gu, Korea, Republic of, 06591
      • Recruiting
      • Seoul ST. Mary's Hospital
      • Contact: Sook Kyung Yum, MD, PhD; Phone Number: +82-2-2258-6993; Email: cookieyyum@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 months (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Major congenital anomaly
• chromosomal / genetic anomaly

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Day 2 liver regional oxygen saturation	regional oxygen saturation of liver obtained from near-infrared spectroscopy (%)	48 to 72 hours of birth
Day 7 liver regional oxygen saturation	regional oxygen saturation of liver obtained from near-infrared spectroscopy (%)	7 (±2) days after birth
Day 14 liver regional oxygen saturation	regional oxygen saturation of liver obtained from near-infrared spectroscopy (%)	14 (±3) days after birth

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul St. Mary's Hospital
• Collaborators: National Research Foundation of Korea
• Investigators: Principal Investigator: Sook Kyung Yum, MD, PhD, Seoul St. Mary's Hospital, Catholic Univeristy of Korea

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2023
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: November 22, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Actual): December 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Heart Defects, Congenital; Cardiovascular Abnormalities; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth; Ductus Arteriosus, Patent
• Other Study ID Numbers: KC22ONSI0820

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes