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| Name | Class |
|---|---|
| National Natural Science Foundation of China | OTHER_GOV |
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Nitro Oxide (NO) inhalation was recognized as an effect treatment of Neonatal Persistent Pulmonary Hypertension (PPHN), while the safety of NO long term application was under investigation. Several research suggested too much NO2 was generated in the lung after long term (> 72h) use of NO inhalation, which cause bad effects on PS production.
Sildenafil was proved to be effective to PPHN as NO. This medication has a similar clinical effect but need monitoring of blood pressure. The possible hypotension effect restrict the dosage of sildenafil, which limit the usage of sildenafil in severe PPHN. But we recommend sildenafil to The purpose of the study was to establish if NO continued with sildenafil has the same effect as single NO inhalation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NOS | Experimental | NO inhalation was performed in the first stage(<48h) of PPHN, NO inhalation was replaced by sildenafil in the second stage(>48h). |
|
| NO | Placebo Comparator | NO inhalation was performed during the whole treatment procedure of PPHN. There is no other methods given to treat PPHN during the therapy course. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NO inhalation | Drug | NO inhalation was performed as the only treatment for PPHN during the whole course. |
|
| Measure | Description | Time Frame |
|---|---|---|
| persistent normal pulmonary artery pressure | The pulmonary artery pressure returned back to a normal level(<30mmHg) and last over 48 hours. | 96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Recover without complication | To ensure the safety of the therapies, brain and lung complications of the baby after PPHN is going to be observed 1 month after birth.
| 1 month after therapy |
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Inclusion Criteria:Diagnosed as PPHN in the NICU,primary disease:neonate respiratory distress syndrome,meconium aspiration syndrome of newborn,severe neonatal infectious pneumonia.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhangxue Hu, MM | Contact | 00862368757730 | huzx1@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics,Daping hospital | Recruiting | Chongqing | Chongqing Municipality | 400042 | 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 |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| NO inhalation continued with sildenafil | Drug | NO inhalation was performed as the primary treatment for PPHN in the first 48 hours, NO inhalation will be replaced by sildenafil after 48 hours of therapy. |
|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |