Study of Fluid Collection of the Chest in Children With Pneumonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2004-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Community Acquired Bacterial Pneumonia Paraneumonic Effusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Video Assisted Thorascopic Surgery Thoracostomy Tube Placement & Drainage

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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John Winters, MD

Role: PRINCIPAL_INVESTIGATOR

Helen DeVos Children's Hospital

Locations

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DeVos Children's Hospital

Grand Rapids, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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2003-181

Identifier Type: -

Identifier Source: org_study_id