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NCT Number: NCT00202826

Study of Fluid Collection of the Chest in Children With Pneumonia

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.

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Key information

Conditions

Community Acquired Bacterial Pneumonia Paraneumonic Effusion

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

DeVos Children's Hospital

Grand Rapids, Michigan, 49503, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Video Assisted Thorascopic Surgery Thoracostomy Tube Placement & Drainage

Procedure

Primary outcomes

  1. establish morbidity outcomes

  2. duration of fever

  3. number of procedures

  4. days with a chest drainage device

  5. total hospital days

Secondary outcomes

  1. Days of oxygen requirement

  2. Days of narcotic use

  3. Complication rate

  4. Number of radiographic procedures

Sponsors and collaborators

Lead sponsor

Corewell Health West

Other

Collaborators

  • Helen DeVos Children's Hospital

Registry information

Official study title

Parapneumonic Effusion in Children Study

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Sep 20, 2005
Registry last updated
Dec 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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