Liver Regional Oxygen Saturation in Preterm Patent Ductus Arteriosus

Recruiting

• Conditions: Circulation; Premature Birth; Patent Ductus Arteriosus; Newborn Morbidity
• Interventions: Device: near-infrared spectroscopy based cerebral/somatic oximeter system (INVOS™ system manufactured by Medtronics)

• Registration Number: NCT05639309
• Lead Sponsor: Seoul St. Mary's Hospital

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.

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 Timeline

• Study First Submitted: 2022-11-22
• Study First Submitted QC: 2022-12-05
• Study First Posted: 2022-12-06
• Study Start: 2023-01-13
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-19
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control (no hemodynamically significant patent ductus arteriosus)	near-infrared spectroscopy based cerebral/somatic oximeter system (INVOS™ system manufactured by Medtronics)	no hsPDA based on the same echocardiographic criteria described for the Case group
Case (hemodynamically significant patent ductus arteriosus)	near-infrared spectroscopy based cerebral/somatic oximeter system (INVOS™ system manufactured by Medtronics)	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

Primary Outcome Measures

Name	Time	Method
Day 14 liver regional oxygen saturation	14 (±3) days after birth	regional oxygen saturation of liver obtained from near-infrared spectroscopy (%)
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 (%)

Secondary Outcome Measures

Name	Time	Method
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 (%)

Trial Locations

Locations (1)

Seoul St. Mary's Hospital; 🇰🇷 Seoul, Seocho-Gu, Korea, Republic of