Study of Fluid Collection of the Chest in Children With Pneumonia - Full Text View

Sponsors and Collaborators:	Spectrum Health Hospitals Helen DeVos Children's Hospital
Information provided by:	Spectrum Health Hospitals
ClinicalTrials.gov Identifier:	NCT00202826

Purpose

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.

Condition	Intervention	Phase
Community Acquired Bacterial Pneumonia Paraneumonic Effusion	Procedure: Video Assisted Thorascopic Surgery Thoracostomy Tube Placement & Drainage	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Parapneumonic Effusion in Children Study

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

U.S. FDA Resources

Further study details as provided by Spectrum Health Hospitals:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Days of oxygen requirement
Days of narcotic use
Complication rate
Number of radiographic procedures

Estimated Enrollment:	30
Study Start Date:	November 2003
Estimated Study Completion Date:	March 2004

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.

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00202826

Locations

United States, Michigan
DeVos Children's Hospital
Grand Rapids, Michigan, United States, 49503

Sponsors and Collaborators

Spectrum Health Hospitals

Helen DeVos Children's Hospital

Investigators

Principal Investigator:

John Winters, MD

Helen DeVos Children's Hospital

More Information

No publications provided

Study ID Numbers:	2003-181
Study First Received:	September 13, 2005
Last Updated:	January 16, 2009
ClinicalTrials.gov Identifier:	NCT00202826 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases

Lung Diseases
Pneumonia, Bacterial
Pneumonia

Additional relevant MeSH terms:

Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases

Lung Diseases
Pneumonia, Bacterial
Pneumonia

ClinicalTrials.gov processed this record on September 11, 2009