Clinical trial NCT00202826: Study of Fluid Collection of the Chest in Children With Pneumonia
Official title: Parapneumonic Effusion in Children Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Community Acquired Bacterial Pneumonia
Paraneumonic Effusion
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
Collaborators: name: Helen DeVos Children's Hospital
First posted: 2005-09-20
Enrollment: 30
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: establish morbidity outcomes
measure: duration of fever
measure: number of procedures
measure: days with a chest drainage device
measure: total hospital days
Secondary outcomes:
measure: Days of oxygen requirement
measure: Days of narcotic use
measure: Complication rate
measure: Number of radiographic procedures
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: DeVos Children's Hospital
state: Michigan
Study officials:
affiliation: Helen DeVos Children's Hospital
name: John Winters, MD
role: PRINCIPAL_INVESTIGATOR
References: