Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00202826
Status:
COMPLETED
Last Update Posted:
2021-12-06
First Post:
2005-09-13
Brief Title:
Study of Fluid Collection of the Chest in Children With Pneumonia
Sponsor:
Spectrum Health Hospitals
Organization:
Spectrum Health Hospitals
Study Overview
Official Title:
Parapneumonic Effusion in Children Study
Status:
COMPLETED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None