Clinical Trials Directory

Trials / Completed

CompletedNCT00202826

Study of Fluid Collection of the Chest in Children With Pneumonia

Parapneumonic Effusion in Children Study

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
30 (planned)
Sponsor
Corewell Health West · Academic / Other
Sex
All
Age
0 Years – 18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREVideo Assisted Thorascopic Surgery Thoracostomy Tube Placement & Drainage

Timeline

Start date
2003-11-01
Primary completion
2004-03-01
Completion
2004-03-01
First posted
2005-09-20
Last updated
2021-12-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00202826. Inclusion in this directory is not an endorsement.