Pilot Study to Evaluate the Usefulness of Liver Regional Oxygen Saturation (RSO2) in Preterm Patent Ductus Arteriosus
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patent Ductus Arteriosus
- Sponsor
- Seoul St. Mary's Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Day 14 liver regional oxygen saturation
- Status
- Completed
- Last Updated
- 11 months ago
Overview
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.
Investigators
Sook Kyung Yum
Dr. Sook Kyung Yum
Seoul St. Mary's Hospital
Eligibility Criteria
Inclusion Criteria
- •Gestational age at birth less than 32 weeks
- •Birthweight less than 1,500 grams
Exclusion Criteria
- •Major congenital anomaly
- •chromosomal / genetic anomaly
Outcomes
Primary Outcomes
Day 14 liver regional oxygen saturation
Time Frame: 14 (±3) days after birth
regional oxygen saturation of liver obtained from near-infrared spectroscopy (%)
Day 2 liver regional oxygen saturation
Time Frame: 48 to 72 hours of birth
regional oxygen saturation of liver obtained from near-infrared spectroscopy (%)
Day 7 liver regional oxygen saturation
Time Frame: 7 (±2) days after birth
regional oxygen saturation of liver obtained from near-infrared spectroscopy (%)
Secondary Outcomes
- PDA liver regional oxygen saturation(When hemodynamically significant patent ductus arteriosus is clinically suspected by the attending physician, up to 28th day of life)