Parapneumonic Effusion in Children Study
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Community Acquired Bacterial Pneumonia
- Sponsor
- Spectrum Health Hospitals
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- establish morbidity outcomes
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
establish morbidity outcomes
number of procedures
days with a chest drainage device
duration of fever
total hospital days
Secondary Outcomes
- Days of oxygen requirement
- Days of narcotic use
- Complication rate
- Number of radiographic procedures