Study of Fluid Collection of the Chest in Children With Pneumonia

Phase 3

Completed

• Conditions: Community Acquired Bacterial Pneumonia; Paraneumonic Effusion

• Registration Number: NCT00202826
• Lead Sponsor: Spectrum Health Hospitals

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.

Study Timeline

• Study Start: 2003-11
• Primary Completion: 2004-03
• Study Completion: 2004-03
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Status Verified: 2009-01
• Last Update Submitted: 2021-12-03
• Last Update Posted: 2021-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
days with a chest drainage device
establish morbidity outcomes
number of procedures
duration of fever
total hospital days

Secondary Outcome Measures

Name	Time	Method
Days of oxygen requirement
Days of narcotic use
Complication rate
Number of radiographic procedures

Trial Locations

Locations (1)

DeVos Children's Hospital; 🇺🇸 Grand Rapids, Michigan, United States