Clinical trial NCT02165891: Comparison of Intrapleural Urokinase and Video-Assisted Thorascopic Surgery in the Treatment of Parapneumonic Pleural Effusion in Children
Official title: Prospective Randomized Study Comparing the Efficacy and Safety of Pleural Drainage by Video-Assisted Thoracoscopic With Pleural Drainage by Percutaneous Drain Associated With Urokinase in the Treatment of Parapneumonic Pleural Effusion in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Empyema, Pleural
Lead sponsor: Queen Fabiola Children's University Hospital
Sponsor class: OTHER
First posted: 2014-06-18
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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 :

  1. fever continuing 48h after starting correct antibiotherapy
  2. respiratory distress
  3. mediastinal displacement on the chest X-ray

Exclusion Criteria:

* previous drainage by either Video-Assisted Thoracoscopic or pleural drainage by percutaneous drain associated with urokinase- congenital pulmonary disorders with lung function impairment
* congenital pulmonary disorders with lung function impairment
* chronic pulmonary disease associated with lung function impairment
* hemodynamic instability
* congenital immunodeficiency disease
* secondary immune deficiency induced
* hemostasis disorder (contraindication of thrombolytic therapy)
* pregnancy or breastfeeding patient

Primary outcomes:
measure: duration of drainage
timeFrame: end of drainage defined per protocole as < 1ml/kg/24h with an expected average time of two days to seven days
Secondary outcomes:
measure: length of hospital stay
timeFrame: Hospital departure with an expected average time of two weeks to one month
measure: Duration of oxygen therapy
timeFrame: up to the end of patient hospitalisation with an expected average time of 48 hours to five days
measure: duration of intravenous antibiotic therapy
timeFrame: 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
measure: Duration of fever > 38.5°C
timeFrame: Up to fever resolution, with an average expected time of five days to 14 days
measure: Number of Participants with Serious and Non-Serious Adverse Events
timeFrame: Up to the end of the hospitalisation, until three months corresponding to the end of follow up period
measure: Patient discomfort
timeFrame: Up to chest drain removal with an average expected time of 48 hours up to seven days
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Queen Fabiola University Children Hospital
Study officials:
References: