NCT05639309

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Seoul St. Mary's Hospital · Academic / Other
• Sex: All
• Age: 4 Months
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Patent Ductus Arteriosus
• Circulation
• Newborn Morbidity
• Premature Birth

Interventions

Type	Name	Description
DEVICE	near-infrared spectroscopy based cerebral/somatic oximeter system (INVOS™ system manufactured by Medtronics)	regional oxygen saturation measurement

Timeline

• Start date: 2023-01-13
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2022-12-06
• Last updated: 2025-05-30

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated device study