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NCT05639309 Clinical Trial

Liver Regional Oxygen Saturation in Preterm Patent Ductus Arteriosus

Premature Birth Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05639309
Other study ID # KC22ONSI0820
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 13, 2023
Est. completion date October 31, 2025

Study information
Verified date April 2024
Source Seoul St. Mary's Hospital
Contact Sook Kyung Yum, MD, PhD
Phone +82-2-2258-6993
Email cookieyyum@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date October 31, 2025
Est. primary completion date October 31, 2025
Accepts healthy volunteers No
Gender All
Age group N/A to 4 Months
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Seoul St. Mary's Hospital Seoul Seocho-Gu

Sponsors (2)
Lead Sponsor Collaborator
Seoul St. Mary's Hospital National Research Foundation of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Other Day 2 cerebral regional oxygen saturation regional oxygen saturation of brain obtained from near-infrared spectroscopy (%) 48 to 72 hours of birth
Other Day 7 cerebral regional oxygen saturation regional oxygen saturation of brain obtained from near-infrared spectroscopy (%) 7 (±2) days after birth
Other Day 14 cerebral regional oxygen saturation regional oxygen saturation of brain obtained from near-infrared spectroscopy (%) 14 (±3) days after birth
Other 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
Other Day 2 renal regional oxygen saturation regional oxygen saturation of kidney obtained from near-infrared spectroscopy (%) 48 to 72 hours of birth
Other Day 7 renal regional oxygen saturation regional oxygen saturation of kidney obtained from near-infrared spectroscopy (%) 7 (±2) days after birth
Other Day 14 renal regional oxygen saturation regional oxygen saturation of kidney obtained from near-infrared spectroscopy (%) 14 (±3) days after birth
Other 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
Primary Day 2 liver regional oxygen saturation regional oxygen saturation of liver obtained from near-infrared spectroscopy (%) 48 to 72 hours of birth
Primary Day 7 liver regional oxygen saturation regional oxygen saturation of liver obtained from near-infrared spectroscopy (%) 7 (±2) days after birth
Primary Day 14 liver regional oxygen saturation regional oxygen saturation of liver obtained from near-infrared spectroscopy (%) 14 (±3) days after birth
Secondary 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
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