Liver Regional Oxygen Saturation in Preterm Patent Ductus Arteriosus

Seoul St. Mary's Hospital

Status: Completed

Conditions: Circulation; Newborn Morbidity; Premature Birth; Patent Ductus Arteriosus

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

Study type: Observational

Funder types: Other

Identifiers

NCT05639309

KC22ONSI0820

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: Under 4 months old

Volunteers: No 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

Trial design

40 participants in 2 patient groups

Case (hemodynamically significant patent ductus arteriosus)

Description:

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

Treatment:

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

Control (no hemodynamically significant patent ductus arteriosus)

Description:

no hsPDA based on the same echocardiographic criteria described for the Case group

Treatment:

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