Study of Fluid Collection of the Chest in Children With Pneumonia

NCT00202826 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-12-06

No results posted yet for this study

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.

Conditions

  • Community Acquired Bacterial Pneumonia
  • Paraneumonic Effusion

Interventions

PROCEDURE

Video Assisted Thorascopic Surgery Thoracostomy Tube Placement & Drainage

Sponsors & Collaborators

  • Helen DeVos Children's Hospital

    collaborator OTHER
  • Spectrum Health Hospitals

    lead OTHER

Principal Investigators

  • John Winters, MD · Helen DeVos Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-30
Primary Completion
2004-03-31
Completion
2004-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00202826 on ClinicalTrials.gov