Study of Fluid Collection of the Chest in Children With Pneumonia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Parapneumonic Effusion in Children Study

Conditions
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Community Acquired Bacterial Pneumonia, Paraneumonic Effusion

Intervention / Treatment
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* Procedure: Video Assisted Thorascopic Surgery Thoracostomy Tube Placement & Drainage


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Video Assisted Thorascopic Surgery Thoracostomy Tube Placement & Drainage|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| establish morbidity outcomes |  |  | 
| duration of fever |  |  | 
| number of procedures |  |  | 
| days with a chest drainage device |  |  | 
| total hospital days |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of oxygen requirement |  |  | 
| Days of narcotic use |  |  | 
| Complication rate |  |  | 
| Number of radiographic procedures |  |  |