Brain, Gut and Kidney Blood Flow During Medical Closure of PDA

Study Overview
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Brief Summary
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The purpose of this study is to determine how the medications which are used to close the patent ductus arteriosus (PDA) in preterm infants affect brain, kidney and gut blood flow when compared to infants that are not treated with these medications. The medications being used for PDA closure are indomethacin and neoprofen.

Detailed Description
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All babies requiring medical treatment of their PDA will receive up to 3 doses of medication. For babies enrolled in the control group of this study, she/he will not be treated with either of these medicines.

Official Title
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Comparison of Cerebral, Renal and Mesenteric Perfusion Using Near Infrared Spectroscopy in Neonates During Patent Ductus Arteriosus Closure With Ibuprofen or Indomethacin.

Conditions
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Patent Ductus Arteriosus

Intervention / Treatment
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* Device: INVOS Cerebral/Somatic oximeter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Less than or equal to 32 weeks gestation; Less than or equal to 1250 g; Mechanical ventilation; Echocardiographic findings of PDA with left to right shunting; Medical judgement of neonatologist for medical treatment; Exclusion Criteria: Urine output less than 1 ml/k/hr over previous 12 hours; Serum creatinine greater than 1.5 mg/dL; Platelet count less than 100,000 per cubic mm; Significant skin breakdown at sensor areas; Significant congenital anomalies Intraventricular hemorrhage greater than or equal to grade III
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 |
| --- | --- |
| Indo<br>Infants that are treated with indomethacin | Device: INVOS Cerebral/Somatic oximeter<br>* Placement of sensors on back, abdomen and forehead for measurement of perfusion beginning 1 hour prior to initiation of drug, during medical treatment for PDA and for 24 hours after the last dose. For control infants, monitoring will continue for 48 hours.<br>|
| Neo<br>Infants treated with neoprofen | Device: INVOS Cerebral/Somatic oximeter<br>* Placement of sensors on back, abdomen and forehead for measurement of perfusion beginning 1 hour prior to initiation of drug, during medical treatment for PDA and for 24 hours after the last dose. For control infants, monitoring will continue for 48 hours.<br>|
| Control<br>Infants without PDA | Device: INVOS Cerebral/Somatic oximeter<br>* Placement of sensors on back, abdomen and forehead for measurement of perfusion beginning 1 hour prior to initiation of drug, during medical treatment for PDA and for 24 hours after the last dose. For control infants, monitoring will continue for 48 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in blood flow from baseline in infants treated with indomethacin or neoprofen. Blood flow will be measured in the brain, kidney and mesentery. |  | 48-72 hours | 
| Measure oxygenation/blood flow to brain during PDA treatment |  | Study period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygenation during/after treatment with PDA therapy |  | Study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patent ductus arteriosus, indomethacin, neoprofen, blood flow