Study of Fluid Collection of the Chest in Children With Pneumonia

This study has been completed.
Sponsor:
Collaborator:
Helen DeVos Children's Hospital
Information provided by:
Spectrum Health Hospitals
ClinicalTrials.gov Identifier:
NCT00202826
First received: September 13, 2005
Last updated: January 16, 2009
Last verified: January 2009

September 13, 2005
January 16, 2009
November 2003
Not Provided
  • establish morbidity outcomes
  • duration of fever
  • number of procedures
  • days with a chest drainage device
  • total hospital days
Same as current
Complete list of historical versions of study NCT00202826 on ClinicalTrials.gov Archive Site
  • Days of oxygen requirement
  • Days of narcotic use
  • Complication rate
  • Number of radiographic procedures
Same as current
Not Provided
Not Provided
 
Study of Fluid Collection of the Chest in Children With Pneumonia
Parapneumonic Effusion in Children Study

The purpose of this study is to determine the best treatment for children with a fluid collection in the chest associated with an underlying pneumonia. Researchers generally agree that a child with a large fluid collection in the chest need to have the fluid drained in addition to anitbiotics. There have been many treatments studied in children that have been shown to be effective and safe, but the treatments have never been compared to each other in a randomized controlled study.

The optimal treatment of pediatric parapneumonic effusions remains controversial. The objective of this study is to compare the use of conventional management (antibiotics with thoracostomy tube placement) with primary thorascopic drainage (see protocol). Our hypothesis is that pediatric patients with parapneumonic effusion, regardless of pleural fluid composition and loculations, have decreased morbidity when treated with early thoroscopic adhesiolysis (VATS) compared with conservative treatment.

The ultimate objective of this study is to rationalize treatment decisions. It is our hope that this pilot study will provide the basis for further randomized prospective studies. The expected benefit is that the current treatment and outcome of pediatric parapneumonic effusions will be determined. Insights into the therapy that results in the least morbidity, hospital days, (and therefore cost) will be elucidated. If our hypothesis is valid, then a more aggressive surgical approach to the treatment of a parapneumonic effusion may be warranted. If the hypothesis is not valid, then the appropriate treatment for a parapneumonic effusion, irrespective of institution and personal opinion, should become more apparent.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Community Acquired Bacterial Pneumonia
  • Paraneumonic Effusion
Procedure: Video Assisted Thorascopic Surgery Thoracostomy Tube Placement & Drainage
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 2004
Not Provided

Inclusion Criteria:

  1. consecutive pediatric patients with a bacterial pneumonia and parapneumonic effusion
  2. community acquired disease
  3. children age 0 to 18 years

Exclusion Criteria:

  1. hospital acquired pneumonia
  2. thoracentesis or chest tube drainage outside hospital
  3. patients with incorrected cardiac disease
Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00202826
2003-181
Not Provided
Not Provided
Spectrum Health Hospitals
Helen DeVos Children's Hospital
Principal Investigator: John Winters, MD Helen DeVos Children's Hospital
Spectrum Health Hospitals
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP