NCT00202826

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2003

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

December 6, 2021

Status Verified

January 1, 2009

Enrollment Period

4 months

First QC Date

September 13, 2005

Last Update Submit

December 3, 2021

Conditions

Community Acquired Bacterial PneumoniaParaneumonic Effusion

Outcome Measures

Primary Outcomes (5)

  • establish morbidity outcomes

  • duration of fever

  • number of procedures

  • days with a chest drainage device

  • total hospital days

Secondary Outcomes (4)

  • Days of oxygen requirement

  • Days of narcotic use

  • Complication rate

  • Number of radiographic procedures

Interventions

Video Assisted Thorascopic Surgery Thoracostomy Tube Placement & DrainagePROCEDURE

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • consecutive pediatric patients with a bacterial pneumonia and parapneumonic effusion
  • community acquired disease
  • children age 0 to 18 years

You may not qualify if:

  • hospital acquired pneumonia
  • thoracentesis or chest tube drainage outside hospital
  • patients with incorrected cardiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DeVos Children's Hospital

Grand Rapids, Michigan, 49503, United States

Location

MeSH Terms

Interventions

Drainage

Intervention Hierarchy (Ancestors)

TherapeuticsSurgical Procedures, Operative

Study Officials

  • John Winters, MD

    Helen DeVos Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

November 1, 2003

Primary Completion

March 1, 2004

Study Completion

March 1, 2004

Last Updated

December 6, 2021

Record last verified: 2009-01

Locations

US(1)