Study to Evaluate the Human Infection of the Lower Respiratory Tract in Children at High Risk
- Conditions
- Severe Respiratory Disease
- Registration Number
- NCT00192439
- Lead Sponsor
- MedImmune LLC
- Brief Summary
- Estimate the incidence rate of hMPV infection detected by RT-PCR from frozen nasal wash aspirates in children at high risk for severe LRI disease (hospitalized at \<2 years of age).
- Detailed Description
* A prospective, epdemiological study to estimate the incidence rate of hMPV infection as determined by RT-PCR from frozen nasal wash aspirates taken from children hospitalized with LRI who are at high risk for severe disease.
* No study drug will be administered for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1500
- Be premature (less than 36 weeks gestation) and less than or equal to 12 months of age, and/or
- 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.
- Known HIV infection or a mother with known HIV infection.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (23)
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Lebonheur Children's Medical Center
🇺🇸Memphis, Tennessee, United States
Children's Memorial Hospital
🇺🇸Chicago, Illinois, United States
New England Medical Center
🇺🇸Boston, Massachusetts, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Suny Upstate Medical Univ.
🇺🇸Syracuse, New York, United States
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
University of Western Australia
🇦🇺Perth, Western Australia, Australia
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
Royal Children's Hospital, Murdoch Children's Research Institute
🇦🇺Parkville, Victoria, Australia
The Children's Hospital
🇺🇸Buffalo, New York, United States
Wake Forest Univ. School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
Miller Children's Hospital
🇺🇸Long Beach, California, United States
Children's Hospital and Regional Medical Center
🇺🇸Seattle, Washington, United States
Institute of Pediatrics, University of Milan
🇮🇹Milan, Italy
Univ. of Mannitoba
🇨🇦Winnipeg, Manitoba, Canada
Univ. of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
University Dept. of Paediatrics, Women's and Children's Hospital
🇦🇺North Adelaide, South Australia, Australia
Rhode Island Hospital, Dept. of Pediatrics
🇺🇸Providence, Rhode Island, United States
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada