Liver Regional Oxygen Saturation in Preterm Patent Ductus Arteriosus

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Study to Evaluate the Usefulness of Liver Regional Oxygen Saturation (RSO2) in Preterm Patent Ductus Arteriosus

Conditions
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Patent Ductus Arteriosus, Circulation, Newborn Morbidity, Premature Birth

Intervention / Treatment
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* Device: near-infrared spectroscopy based cerebral/somatic oximeter system (INVOS™ system manufactured by Medtronics)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age at birth less than 32 weeks Birthweight less than 1,500 grams Exclusion Criteria: Major congenital anomaly chromosomal / genetic anomaly

Ages Eligible for Study
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Maximum Age: 4 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case (hemodynamically significant patent ductus arteriosus)<br>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 | Device: near-infrared spectroscopy based cerebral/somatic oximeter system (INVOS™ system manufactured by Medtronics)<br>* regional oxygen saturation measurement<br>|
| Control (no hemodynamically significant patent ductus arteriosus)<br>no hsPDA based on the same echocardiographic criteria described for the Case group | Device: near-infrared spectroscopy based cerebral/somatic oximeter system (INVOS™ system manufactured by Medtronics)<br>* regional oxygen saturation measurement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |