Evaluation of the Brain and Renal Regional Oxygenation Using NIRS in Preterm Infants

Study Overview
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Brief Summary
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This study evaluates the brain and renal oxygenation using near infrared spectroscopy in preterm infants with persistent ductus arteriosus

Detailed Description
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Patent ductus arteriosus (PDA) is common in preterm infants. In the presence of a large PDA, significant systemic to pulmonary shunting occurs, which may result in pulmonary hyperperfusion and systemic hypoperfusion. The evidence on PDA effect on brain and renal tissue oxygenation, measured by Near Infrared Spectroscopy is still controversial. This study aims to evaluate the brain and renal oxygenation using near infrared spectroscopy (NONIN SenSmart model X-100) in 3 groups of preterm infants: 1) closed ductus arteriosus, 2) persistent ductus arteriosus, 3) hemodynamicaly significant ductus arteriosus.

Official Title
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Evaluation of the Brain and Renal Regional Oxygenation Using Near Infrared Spectroscopy (NIRS) Method in Very Low Birth Weight (<1500 g) Infants

Conditions
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Pre-Term, Persistent Ductus Arteriosus

Intervention / Treatment
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* Device: NONIN SenSmart model X-100 near- infrared spectrometer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: preterm infants with gestation age of < 32 weeks birth weight < 1500g > 72 hours of age. Exclusion Criteria: cardiovascular, renal, cerebral congenital defects, confirmed sepsis, no parental consent

Ages Eligible for Study
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Minimum Age: 22 Weeks
Maximum Age: 32 Weeks

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 |
| --- | --- |
| group1<br>preterm infant with closed ductus arteriosus, <32 weeks birth weight < 1500g, and > 72 hours of age | Device: NONIN SenSmart model X-100 near- infrared spectrometer<br>* for to measure cerebral (cSO2) and renal (rSO2 ) regional tissue oxygen saturation on the day after echocardiography was done. The sensors were placed on the right/left forehead and the right/left lateral posterior flank<br>* Other names: GE LOGIQ S8 XDclear 2.0 ultrasoud;|
| group2<br>preterm infant with PDA < 32 weeks, birth weight < 1500g, and > 72 hours of age | Device: NONIN SenSmart model X-100 near- infrared spectrometer<br>* for to measure cerebral (cSO2) and renal (rSO2 ) regional tissue oxygen saturation on the day after echocardiography was done. The sensors were placed on the right/left forehead and the right/left lateral posterior flank<br>* Other names: GE LOGIQ S8 XDclear 2.0 ultrasoud;|
| group3<br>preterm infant with hemodynamically significant PDA < 32 weeks, birth weight < 1500g, and > 72 hours of age | Device: NONIN SenSmart model X-100 near- infrared spectrometer<br>* for to measure cerebral (cSO2) and renal (rSO2 ) regional tissue oxygen saturation on the day after echocardiography was done. The sensors were placed on the right/left forehead and the right/left lateral posterior flank<br>* Other names: GE LOGIQ S8 XDclear 2.0 ultrasoud;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences of the mean values of regional oxygenation of the brain and renal | Cerebral and renal regional tissue oxygen saturation monitoring on the day after echocardiography was done | from Day 4 of live up to 36 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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near-infrared spectroscopy, preterm infant, echocardiography