Study of Fluid Collection of the Chest in Children With Pneumonia
Primary Purpose
Community Acquired Bacterial Pneumonia, Paraneumonic Effusion
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Video Assisted Thorascopic Surgery Thoracostomy Tube Placement & Drainage
Sponsored by
About this trial
This is an interventional treatment trial for Community Acquired Bacterial Pneumonia
Eligibility Criteria
Inclusion Criteria: consecutive pediatric patients with a bacterial pneumonia and parapneumonic effusion community acquired disease children age 0 to 18 years Exclusion Criteria: hospital acquired pneumonia thoracentesis or chest tube drainage outside hospital patients with incorrected cardiac disease
Sites / Locations
- DeVos Children's Hospital
Outcomes
Primary Outcome Measures
establish morbidity outcomes
duration of fever
number of procedures
days with a chest drainage device
total hospital days
Secondary Outcome Measures
Days of oxygen requirement
Days of narcotic use
Complication rate
Number of radiographic procedures
Full Information
NCT ID
NCT00202826
First Posted
September 13, 2005
Last Updated
December 3, 2021
Sponsor
Spectrum Health Hospitals
Collaborators
Helen DeVos Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00202826
Brief Title
Study of Fluid Collection of the Chest in Children With Pneumonia
Official Title
Parapneumonic Effusion in Children Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
March 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Spectrum Health Hospitals
Collaborators
Helen DeVos Children's Hospital
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community Acquired Bacterial Pneumonia, Paraneumonic Effusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Video Assisted Thorascopic Surgery Thoracostomy Tube Placement & Drainage
Primary Outcome Measure Information:
Title
establish morbidity outcomes
Title
duration of fever
Title
number of procedures
Title
days with a chest drainage device
Title
total hospital days
Secondary Outcome Measure Information:
Title
Days of oxygen requirement
Title
Days of narcotic use
Title
Complication rate
Title
Number of radiographic procedures
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
consecutive pediatric patients with a bacterial pneumonia and parapneumonic effusion
community acquired disease
children age 0 to 18 years
Exclusion Criteria:
hospital acquired pneumonia
thoracentesis or chest tube drainage outside hospital
patients with incorrected cardiac disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Winters, MD
Organizational Affiliation
Helen DeVos Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
DeVos Children's Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Fluid Collection of the Chest in Children With Pneumonia
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