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| Name | Class |
|---|---|
| National Research Foundation of Korea | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case (hemodynamically significant patent ductus arteriosus) | 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 |
| |
| Control (no hemodynamically significant patent ductus arteriosus) | no hsPDA based on the same echocardiographic criteria described for the Case group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| near-infrared spectroscopy based cerebral/somatic oximeter system (INVOS™ system manufactured by Medtronics) | Device | regional oxygen saturation measurement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Day 2 liver regional oxygen saturation | regional oxygen saturation of liver obtained from near-infrared spectroscopy (%) | 48 to 72 hours of birth |
| Day 7 liver regional oxygen saturation | regional oxygen saturation of liver obtained from near-infrared spectroscopy (%) | 7 (±2) days after birth |
| Day 14 liver regional oxygen saturation | regional oxygen saturation of liver obtained from near-infrared spectroscopy (%) | 14 (±3) days after birth |
| Measure | Description | Time Frame |
|---|---|---|
| PDA liver regional oxygen saturation | regional oxygen saturation of liver obtained from near-infrared spectroscopy (%) | When hemodynamically significant patent ductus arteriosus is clinically suspected by the attending physician, up to 28th day of life |
| Measure | Description | Time Frame |
|---|---|---|
| Day 2 cerebral regional oxygen saturation | regional oxygen saturation of brain obtained from near-infrared spectroscopy (%) | 48 to 72 hours of birth |
| Day 7 cerebral regional oxygen saturation | regional oxygen saturation of brain obtained from near-infrared spectroscopy (%) |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Sook Kyung Yum, MD, PhD | Seoul St. Mary's Hospital, Catholic Univeristy of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul St. Mary's Hospital | Seoul | Seocho-Gu | 06591 | South Korea |
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| ID | Term |
|---|---|
| D004374 | Ductus Arteriosus, Patent |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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| 7 (±2) days after birth |
| Day 14 cerebral regional oxygen saturation | regional oxygen saturation of brain obtained from near-infrared spectroscopy (%) | 14 (±3) days after birth |
| PDA cerebral regional oxygen saturation | regional oxygen saturation of brain obtained from near-infrared spectroscopy (%) | When hemodynamically significant patent ductus arteriosus is clinically suspected by the attending physician, , up to 28th day of life |
| Day 2 renal regional oxygen saturation | regional oxygen saturation of kidney obtained from near-infrared spectroscopy (%) | 48 to 72 hours of birth |
| Day 7 renal regional oxygen saturation | regional oxygen saturation of kidney obtained from near-infrared spectroscopy (%) | 7 (±2) days after birth |
| Day 14 renal regional oxygen saturation | regional oxygen saturation of kidney obtained from near-infrared spectroscopy (%) | 14 (±3) days after birth |
| PDA renal regional oxygen saturation | regional oxygen saturation of kidney obtained from near-infrared spectroscopy (%) | When hemodynamically significant patent ductus arteriosus is clinically suspected by the attending physician, , up to 28th day of life |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |