Circulation, Newborn Morbidity, Patent Ductus Arteriosus, Premature Birth
Conditions
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.
Interventions
DEVICEnear-infrared spectroscopy based cerebral/somatic oximeter system (INVOS™ system manufactured by Medtronics)
regional oxygen saturation measurement
Sponsors
National Research Foundation of Korea
Seoul St. Mary's Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 4 Months
Healthy volunteers
No
Inclusion criteria
* Gestational age at birth less than 32 weeks * Birthweight less than 1,500 grams
Exclusion criteria
* Major congenital anomaly * chromosomal / genetic anomaly
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 (%) |
| Day 14 liver regional oxygen saturation | 14 (±3) days after birth | regional oxygen saturation of liver obtained from near-infrared spectroscopy (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 (%) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Day 2 renal regional oxygen saturation | 48 to 72 hours of birth | regional oxygen saturation of kidney obtained from near-infrared spectroscopy (%) |
| Day 7 renal regional oxygen saturation | 7 (±2) days after birth | regional oxygen saturation of kidney obtained from near-infrared spectroscopy (%) |
| Day 7 cerebral regional oxygen saturation | 7 (±2) days after birth | regional oxygen saturation of brain obtained from near-infrared spectroscopy (%) |
| PDA renal 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 kidney obtained from near-infrared spectroscopy (%) |
| Day 14 renal regional oxygen saturation | 14 (±3) days after birth | regional oxygen saturation of kidney obtained from near-infrared spectroscopy (%) |
| Day 14 cerebral regional oxygen saturation | 14 (±3) days after birth | regional oxygen saturation of brain obtained from near-infrared spectroscopy (%) |
| Day 2 cerebral regional oxygen saturation | 48 to 72 hours of birth | regional oxygen saturation of brain obtained from near-infrared spectroscopy (%) |
| PDA cerebral 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 brain obtained from near-infrared spectroscopy (%) |
Countries
South Korea
Outcome results
None listed