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To determine whether oral or intravenous ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm infants.
To determine whether oral or intravenous ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm infants.Seventy ELBW preterm infants with patent ductus arteriosis will be enrolled in this prospective-randomized study. Patients will receive either intravenous or oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.
One of the following echocardiographic criteria of a duct size >1.5 mm, a left atrium-to-aorta ratio >1.5, left-to-right shunting of blood, end diastolic reversal of blood flow in the aorta, or poor cardiac function in addition signs of patent ductus arteriosis determined the need of ibuprofen treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intravenous ibuprofen | Active Comparator | Extremely low birth weight patients receiving iv ibuprofen |
|
| Oral ibuprofen | Active Comparator | Extremely low birth weight patients receiving oral ibuprofen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral ibuprofen | Drug | oral or iv ibuprofen in 10, 5 and 5 mg/kg/day with 24 hr intervals |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy and Safety of Oral Versus Intravenous Ibuprofen... ID: STO5336205575 | To compare the closure rate of patent ductus arteriosus after intravenous or oral ibuprofen treatment | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy and Safety of Oral Versus Intravenous Ibuprofen | Evaluation of renal tolerance and complications | Results will be identified in 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Omer Erdeve | Zekai Tahir Burak Women's Health Research and Education Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zekai Tahir Burak Maternity Teaching Hospital | Ankara | 06600 | Turkey (Türkiye) |
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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 |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |