Clinical trial NCT05639309: Liver Regional Oxygen Saturation in Preterm Patent Ductus Arteriosus
Official title: Pilot Study to Evaluate the Usefulness of Liver Regional Oxygen Saturation (RSO2) in Preterm Patent Ductus Arteriosus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patent Ductus Arteriosus
Circulation
Newborn Morbidity
Premature Birth
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
First posted: 2022-12-06
Enrollment: 40
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants born at less than 32 weeks' gestation and/or 1,500 grams at birth, who accepts informed consent from the their legal guardians (parents) will be included. Those with major congenital anomaly or genetic abnormality who are at high risk for adverse outcome and compensated circulatory status will be excluded.

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.

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

Primary outcomes:
measure: Day 2 liver regional oxygen saturation
timeFrame: 48 to 72 hours of birth
measure: Day 7 liver regional oxygen saturation
timeFrame: 7 (±2) days after birth
measure: Day 14 liver regional oxygen saturation
timeFrame: 14 (±3) days after birth
Secondary outcomes:
measure: PDA liver regional oxygen saturation
timeFrame: When hemodynamically significant patent ductus arteriosus is clinically suspected by the attending physician, up to 28th day of life
Other outcomes:
measure: Day 2 cerebral regional oxygen saturation
timeFrame: 48 to 72 hours of birth
measure: Day 7 cerebral regional oxygen saturation
timeFrame: 7 (±2) days after birth
measure: Day 14 cerebral regional oxygen saturation
timeFrame: 14 (±3) days after birth
measure: PDA cerebral regional oxygen saturation
timeFrame: When hemodynamically significant patent ductus arteriosus is clinically suspected by the attending physician, , up to 28th day of life
measure: Day 2 renal regional oxygen saturation
timeFrame: 48 to 72 hours of birth
measure: Day 7 renal regional oxygen saturation
timeFrame: 7 (±2) days after birth
measure: Day 14 renal regional oxygen saturation
timeFrame: 14 (±3) days after birth
measure: PDA renal regional oxygen saturation
timeFrame: When hemodynamically significant patent ductus arteriosus is clinically suspected by the attending physician, , up to 28th day of life
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
state: Seocho-Gu
Study officials:
affiliation: Seoul St. Mary's Hospital, Catholic Univeristy of Korea
name: Sook Kyung Yum, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: