Study of Fluid Collection of the Chest in Children With Pneumonia

Community Acquired Bacterial Pneumonia Clinical Trial

Official title:

Parapneumonic Effusion in Children Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00202826
• Other study ID #: 2003-181
• Status: Completed
• Phase: Phase 3
• Start date: November 2003
• Est. completion date: March 2004

Study information

• Verified date: January 2009
• Source: Spectrum Health Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Community Acquired Bacterial Pneumonia
• Paraneumonic Effusion
• Pneumonia
• Pneumonia, Bacterial

Intervention

Procedure:
• Video Assisted Thorascopic Surgery Thoracostomy Tube Placement & Drainage

Locations

Country	Name	City	State
United States	DeVos Children's Hospital	Grand Rapids	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Spectrum Health Hospitals	Helen DeVos Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	establish morbidity outcomes
Primary	duration of fever
Primary	number of procedures
Primary	days with a chest drainage device
Primary	total hospital days
Secondary	Days of oxygen requirement
Secondary	Days of narcotic use
Secondary	Complication rate
Secondary	Number of radiographic procedures