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| Name | Class |
|---|---|
| West China Second University Hospital | OTHER |
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The use of bosentan, sildenafil and tadalafil in neonates with persistent pulmonary hypertension (PPHN) depends mostly on the empirical experience of pediatricians. Moreover, the recommended dose of those three drugs in treating PPHN remains controversial. Therefore, our aim is to study the pharmacokinetics and pharmacodynamics of bosentan, sildenafil and tadalafil in neonates of PPHN then dose a tailor-made therapeutic regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment(bosentan, sildenafil and tadalafil) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bosentan Tablets | Drug | 2mg/kg, bid |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Oxygenation index | Oxygenation index=(fraction of inspired oxygen*mean airway pressure)/the partial pressure of arterial oxygen | The first 72 hours of the initial treatment |
| The change of hemodynamics |
| Through study completion, an average of 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of hospitalization | Duration of initial therapy | Within the first 28 days of patients' life |
| Death | Death in the first 28 days of life |
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Inclusion Criteria:
Exclusion Criteria:
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Neonates suffered from persistent pulmonary hypertension
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Second University Hospital | Chengdu | Sichuan | 610041 | China |
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| ID | Term |
|---|---|
| D010547 | Persistent Fetal Circulation Syndrome |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007232 | Infant, Newborn, Diseases |
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| ID | Term |
|---|---|
| D000077300 | Bosentan |
| D000068677 | Sildenafil Citrate |
| D000068581 | Tadalafil |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Sildenafil Tablet |
| Drug |
1mg/kg, q6h/q8h |
|
| Tadalafil Tablets | Drug | 1mg/kg, qd |
|
| Within the first 28 days of patients' life |
| Adverse events | Drug-related adverse events and serious adverse events | Through study completion, an average of 5 days |
| Sequelae of PPHN | Including cerebral palsy, hearing impairment, neurodevelopmental outcome etc | Through study completion and a 6-month visit |
| The need of extra support | Besides the initial therapy (bosentan, sildenafil and/or tadalafil), other support such as inhaled nitric oxide (iNO), inotropic agents or Extracorporeal Membrane Oxygenation (ECMO) | Through study completion, an average of 5 days |
| Pulse oxygen saturation | Pulse oxygen saturation（%） | The first 72 hours of the initial treatment |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D002243 | Carbolines |
| D011725 | Pyridines |
| D026121 | Indole Alkaloids |
| D007211 | Indoles |
| D006575 | Heterocyclic Compounds, 3-Ring |