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| Name | Class |
|---|---|
| Seoul National University Bundang Hospital | OTHER |
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The purpose of this study is to investigate the pharmacokinetics of sildenafil which is used as treatment of pulmonary hypertension in neonate and preterm infant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | sildenafil treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sildenafil | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC(0-t) | 5 times drug level after 5 doses (pre30min/post 30min, 1hr, 2hr, 4hr) pharmacokinetics | t up to 5 weeks |
| Cmax(0-t) | 5 times drug level after 5 doses (pre30min/post 30min, 1hr, 2hr, 4hr) pharmacokinetics | t up to 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in pulmonary arterial hypertension at 5 weeks | Echocardiography
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Han-Suk Kim, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea | ||
| Seoul National University Children's Hospital |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| pre, 2 weeks, 5 weeks of drug administration |
| respiratory severity score | Mean airway pressure x FiO2 | pre, 2 weeks, 5 weeks after administration |
| Seoul |
| 110-744 |
| South Korea |
| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |