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The purpose of this study is to examine the influence medical or surgical treatment for patent ductus arteriosus in preterm infants on cerebral and renal tissue oxygenation and on cardiac output.
In this observational trial the investigators want to examine whether clinical or echocardiographic parameters of patent ductus arteriosus are related to
as measured by near infrared spectroscopy
and to
as measured by electrical cardiometry.
The investigators want to examine the impact of surgical and medical treatment for patent ductus on these parameters. The investigators want to compare the change of these parameters between responders to medical treatment and nonresponders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indomethacin | Infants treated with Indomethacin |
| |
| Ibuprofen | Infants treated with Ibuprofen |
| |
| Ligation | Infants undergoing surgical ligation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indomethacin | Drug | 3 doses of 0,2mg/kg every 12h (first week of life) or every 8h (after first week of life) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of cerebral tissue oxygen saturation during treatment for patent ductus arteriosus | from 10 minutes before start of infusion until 4 hours after end of transfusion |
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Inclusion Criteria:
Exclusion Criteria:
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Preterm neonates with patent ductus arteriosus treated in our hospital
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| Name | Affiliation | Role |
|---|---|---|
| Manuel B Schmid, Dr. med. | University of Ulm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center | Ulm | Baden-Wurttemberg | 89075 | Germany |
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| ID | Term |
|---|---|
| D004374 | Ductus Arteriosus, Patent |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Surgical Ligation | Procedure | In nonresponders to medical treatment with persistent hemodynamically relevant patent ductus arteriosus surgical ligation is performed. |
|
| Ibuprofen | Drug | 3 doses every 24h; first dose 10mg/kg, second and third dose 5mg/kg |
|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |