Study to Evaluate the Human Infection of the Lower Respiratory Tract in Children at High Risk
NCT ID: NCT00192439
Last Updated: 2007-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1500 participants
OBSERVATIONAL
2003-12-31
2006-12-31
Brief Summary
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Detailed Description
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* No study drug will be administered for this study.
Conditions
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Study Design
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DEFINED_POPULATION
OTHER
Interventions
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High Risk Respiratory Disease
Eligibility Criteria
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Inclusion Criteria
* Be less than or equal to 24 months of age with CHD (other than uncomplicated small atrial or ventricular septal defects or patent ductus arteriosus) that is judged to be hemodynamically significant, and/or
* Be less than or equal to 24 months of age with CLD of prematurity (BPD) requiring medical intervention/management (i.e., supplemental oxygen, steroids, bronchodilators, or diuretics within the previous 6 months).
* Hospital admission diagnosis referable to an acute lower respiratory tract infection or cardio/respiratory illness with a presumed respiratory infection (e.g., bronchiolitis, bronchitis, or pneumonia or cardiac decompensation associated with respiratory infection); admission must occur between October 1 and June 30 for northern hemisphere sites, and between March 1 and November 30 for southern hemisphere sites.
* Study enrollment within 2 days after hospitalization.
* Admission from the community to the Pediatric ward, Neonatal Intensive Care Unit, or the Intensive Care Unit.
* Have written informed consent obtained from the parent or legal guardian prior to study entry.
Exclusion Criteria
1 Day
24 Months
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
Principal Investigators
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Margarita Gomez, M.D.
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
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Miller Children's Hospital
Long Beach, California, United States
The Children's Hospital
Denver, Colorado, United States
Children's Memorial Hospital
Chicago, Illinois, United States
New England Medical Center
Boston, Massachusetts, United States
The Children's Hospital
Buffalo, New York, United States
Schneider Children's Hospital, Long Island Jewish Medical Center
New Hyde Park, New York, United States
Univ. of Rochester Medical Center
Rochester, New York, United States
Suny Upstate Medical Univ.
Syracuse, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest Univ. School of Medicine
Winston-Salem, North Carolina, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital, Dept. of Pediatrics
Providence, Rhode Island, United States
Lebonheur Children's Medical Center
Memphis, Tennessee, United States
Univ. of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Children's Hospital and Regional Medical Center
Seattle, Washington, United States
University Dept. of Paediatrics, Women's and Children's Hospital
North Adelaide, South Australia, Australia
Royal Children's Hospital, Murdoch Children's Research Institute
Parkville, Victoria, Australia
University of Western Australia
Perth, Western Australia, Australia
University of Alberta
Edmonton, Alberta, Canada
Univ. of Mannitoba
Winnipeg, Manitoba, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Institute of Pediatrics, University of Milan
Milan, , Italy
Countries
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Other Identifiers
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MI-CP096
Identifier Type: -
Identifier Source: org_study_id