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Study of Fluid Collection of the Chest in Children With Pneumonia

Parapneumonic Effusion in Children Study

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00202826
Enrollment
30
Registered
2005-09-20
Start date
2003-11-30
Completion date
2004-03-31
Last updated
2021-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community Acquired Bacterial Pneumonia, Paraneumonic Effusion

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.

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.

Interventions

PROCEDUREVideo Assisted Thorascopic Surgery Thoracostomy Tube Placement & Drainage

Sponsors

Helen DeVos Children's Hospital
CollaboratorOTHER
Corewell Health West
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
total hospital days
establish morbidity outcomes
duration of fever
number of procedures
days with a chest drainage device

Secondary

MeasureTime frame
Days of narcotic use
Complication rate
Number of radiographic procedures
Days of oxygen requirement

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026