Study of Fluid Collection of the Chest in Children With Pneumonia
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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 |
- establish morbidity outcomes
- duration of fever
- number of procedures
- days with a chest drainage device
- total hospital days
- 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 |
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 |
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| United States, Michigan | |
| DeVos Children's Hospital | |
| Grand Rapids, Michigan, United States, 49503 | |
| 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 May 16, 2013