Status:
COMPLETED
Bacterial Pulmonary Infection in PICU
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Bacterial Infection
Eligibility:
All Genders
2-17 years
Brief Summary
The purpose of this study is to develop a scoring system to allow doctors to accurately identify children on a mechanical ventilator who have bacterial pneumonia. Currently this diagnosis is very diff...
Detailed Description
The primary objective of this prospective cohort study is to derive a clinical score for predicting the absence of bacterial pulmonary infection in children requiring mechanical ventilation. This stud...
Eligibility Criteria
Inclusion
- Parent or legal guardian has signed the informed consent.
- Age greater than 48 weeks post-conception and less than 18 years of age.
- Requiring mechanical ventilation in the intensive care unit (subjects will not be intubated solely for the purpose of this study).
- Presence of an abnormal chest x-ray (CXR) as determined by the primary care team (Note: if the attending radiologist disagrees with the reading of "abnormal CXR," the subject will be followed for safety and replaced for analysis).
- Initiation of antibiotics by the assigned health care providers for suspected bacterial pneumonia (must be less than or equal to 12 hours prior to undergoing non-bronchoscopic bronchoalveolar lavage \[NB-BAL\]).
Exclusion
- Presence of severe hypoxia (PaO2/FIO2 \< 120).
- Documented or suspected increased intracranial pressure.
- Hemodynamic instability, defined as one of the following in the 4 hours preceding study entry:
- Initiation of any inotropic or vasopressor agents at any dose to improve blood pressure or tissue perfusion.
- Increase in infusion rate of any inotropic or vasopressor agents to improve blood pressure or tissue perfusion.
- Receipt of intravenous (IV) or oral (PO) antibiotics for suspected bacterial pneumonia for greater than or equal to 12 hours prior to non-bronchoscopic bronchoalveolar lavage (NB-BAL).
- Treatment for a previous episode of suspected bacterial pneumonia within three days prior to NB-BAL.
- Coagulopathy:
- Documented platelet count \<50,000 x 10\^6/mL at the time of enrollment (Exception: The subject may be enrolled if he/she receives a platelet infusion as a part of routine care that is completed within one hour of NB-BAL initiation),
- Extra-corporeal circuit, requiring anticoagulation, or
- Clinically apparent bleeding deemed important by either the PI or attending intensivist.
- Previous enrollment into this study.
- Cardiopulmonary instability during routine suctioning within 6 hours of NB-BAL.
- Oscillatory ventilation.
- Cystic fibrosis.
- Single ventricle physiology.
- Positive pleural fluid culture results prior to Day -1 during the current hospitalization.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00271531
Start Date
April 1 2006
End Date
May 1 2008
Last Update
August 12 2011
Active Locations (4)
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1
Kosair Children's Hospital
Louisville, Kentucky, United States, 40202
2
Washington University in St. Louis
St Louis, Missouri, United States, 63110
3
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
4
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104