Comparison of Intrapleural Urokinase and Video-Assisted Thorascopic Surgery in the Treatment of Parapneumonic Pleural Effusion in Children

Last updated: July 3, 2018
Sponsor: Queen Fabiola Children's University Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Lung Disease

Pleural Effusion

Treatment

N/A

Clinical Study ID

NCT02165891
P2013/PE1
  • Ages 1-16
  • All Genders

Study 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

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

Exclusion Criteria:

  • previous drainage by either Video-Assisted Thoracoscopic or pleural drainage bypercutaneous drain associated with urokinase- congenital pulmonary disorders with lungfunction 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

Study Design

Total Participants: 40
Study Start date:
February 01, 2015
Estimated Completion Date:
June 30, 2020

Connect with a study center

  • Queen Fabiola University Children Hospital

    Brussels, 1020
    Belgium

    Active - Recruiting

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