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Despite the improvement in the technology available for diagnosing and treating empyema, the management of empyema in children remains controversial.
The purpose of this study is to compare the efficacy and safety of two common technical approach used for pleural effusion drainage in the treatment of childhood empyema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Urokinase | Other | insertion of a chest drain with urokinase instillation |
|
| VATS | Other | primary video-assisted thorascopic surgery Other interventions except drainage procedure are the same in both arms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insertion of a chest drain with urokinase instillation | Drug | Other interventions except drainage procedure are the same in both arms |
|
| Measure | Description | Time Frame |
|---|---|---|
| duration of drainage | end of drainage defined per protocole as < 1ml/kg/24h with an expected average time of two days to seven days |
| Measure | Description | Time Frame |
|---|---|---|
| length of hospital stay | Hospital departure with an expected average time of two weeks to one month | |
| Duration of oxygen therapy | up to the end of patient hospitalisation with an expected average time of 48 hours to five days |
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Inclusion Criteria:
patients under the age of 17
pleural fluid depth of at least 15mm, confirmed by ultrasound
at least one of the following severity criteria :
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Fabiola University Children Hospital | Recruiting | Brussels | 1020 | Belgium |
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| primary video-assisted thorascopic surgery | Procedure |
|
| duration of intravenous antibiotic therapy | up to the last intravenous antibiotic injection, minimum of 48 hours for a simple pleural effusion and a minimum of 14 days for an empyema with a maximum of one month |
| Duration of fever > 38.5°C | Up to fever resolution, with an average expected time of five days to 14 days |
| Number of Participants with Serious and Non-Serious Adverse Events | Up to the end of the hospitalisation, until three months corresponding to the end of follow up period |
| Patient discomfort | Up to chest drain removal with an average expected time of 48 hours up to seven days |
| ID | Term |
|---|---|
| D016724 | Empyema, Pleural |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D004653 | Empyema |
| D013492 | Suppuration |
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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