Study of Fluid Collection of the Chest in Children With Pneumonia

This study has been completed.
Sponsor:
Collaborator:
Helen DeVos Children's Hospital
Information provided by:
Spectrum Health Hospitals
ClinicalTrials.gov Identifier:
NCT00202826
First received: September 13, 2005
Last updated: January 16, 2009
Last verified: January 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Parapneumonic Effusion in Children Study

Resource links provided by NLM:


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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional relevant MeSH terms:
Pneumonia, Bacterial
Pneumonia
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on July 20, 2014