Changes in Renal and Splanchnic Oxygenation During Ibuprofen Treatment for Patent Ductus Arterious

Study Overview
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Brief Summary
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Patent ductus arterious(PDA)is frequently seen and potentially pathologic in preterm infants. Near-infrared spectroscopy is a simple bedside tool to analyse the changes in the renal and splanchnic tissue oxygenation index and fractional tissue oxygen extraction and may be helpful to measure effects of ibuprofen treatment for PDA in preterm infants.

Detailed Description
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Patent ductus arterious (PDA) is the most common cardiovascular abnormality in preterm infants.There are clear associations between a PDA and decreased renal and splanchnic blood flow. The aim is to monitor, using near-infrared spectroscopy, the effect of ibuprofen on the fractional tissue (renal and mesenteric) oxygen extraction (FTOE) in preterm newborns during ibuprofen of the treatment PDA.

Official Title
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Observational Study of Near Infrared Spectroscopy to Monitor Renal and Splanchnic Oxygenation During Ibuprofen Treatment for Patent Ductus Arterious in Preterm Infants

Conditions
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Ductus Arteriosus, Patent

Intervention / Treatment
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* Device: Near-infrared spectroscopy (NIRS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age <32 weeks and <1500 g Echocardiographic evidence of hemodynamically significant patent ductus arterious Exclusion Criteria: Major congenital anomalies Intraventricular hemorrhage of grade 3 within the previous 24 hours Serum creatinine level 1.5 mg%,serum urea nitrogen concentration >50 mg%, Platelet count 60 000/mL3, a tendency to bleed (defined by the presence of hematuria, blood in the endotracheal aspirate, gastric aspirate, or stools and/or oozing from puncture sites) Hyperbilirubinemia necessitating exchange transfusion

Ages Eligible for Study
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Minimum Age: 2 Days

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 |
| --- | --- |
| Treatment with ibuprofen<br>Gestational age <32 weeks and <1500 g, postnatal age older than 48 hours and echocardiographic evidence of hemodynamically significant PDA | Device: Near-infrared spectroscopy (NIRS)<br>* Non-invasive monitoring device measures the quantity of reflected light photons as a function of two wavelengths, and determines the spectral absorption of the underlying tissue.<br>* Other names: INVOS 4100 oximeter, Somanetics,;|
| Controls<br>Gestational age <32 weeks and <1500 g, postnatal age older than 48 hours and without significant PDA | Device: Near-infrared spectroscopy (NIRS)<br>* Non-invasive monitoring device measures the quantity of reflected light photons as a function of two wavelengths, and determines the spectral absorption of the underlying tissue.<br>* Other names: INVOS 4100 oximeter, Somanetics,;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |