Study to Evaluate the Human Infection of the Lower Respiratory Tract in Children at High Risk
This study has been completed.
Sponsor:
MedImmune LLC
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00192439
First received: September 12, 2005
Last updated: May 4, 2007
Last verified: May 2007
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Purpose
- 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).
| Condition | Intervention |
|---|---|
|
Severe Respiratory Disease |
Behavioral: High Risk Respiratory Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Defined Population Observational Model: Natural History Time Perspective: Cross-Sectional Time Perspective: Prospective |
| Official Title: | A Study to Describe the Incidence Rate and Clinical Features of Human Meta Pneumovirus (hMPV) Infection of the Lower Respiratory Tract in Hospitalized Children at High Risk for Severe Disease |
Further study details as provided by MedImmune LLC:
| Enrollment: | 1500 |
| Study Start Date: | December 2003 |
| Study Completion Date: | December 2006 |
- 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.
Eligibility| Ages Eligible for Study: | up to 24 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Known HIV infection or a mother with known HIV infection.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00192439
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| United States, California | |
| Miller Children's Hospital | |
| Long Beach, California, United States, 90806 | |
| United States, Colorado | |
| The Children's Hospital | |
| Denver, Colorado, United States, 80218 | |
| United States, Illinois | |
| Children's Memorial Hospital | |
| Chicago, Illinois, United States, 60614 | |
| United States, Massachusetts | |
| New England Medical Center | |
| Boston, Massachusetts, United States, 02111 | |
| United States, New York | |
| The Children's Hospital | |
| Buffalo, New York, United States, 14222 | |
| Schneider Children's Hospital, Long Island Jewish Medical Center | |
| New Hyde Park, New York, United States, 11040 | |
| Univ. of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| Suny Upstate Medical Univ. | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| Wake Forest Univ. School of Medicine | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Pennsylvania | |
| Children's Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 80218 | |
| United States, Rhode Island | |
| Rhode Island Hospital, Dept. of Pediatrics | |
| Providence, Rhode Island, United States, 02903 | |
| United States, Tennessee | |
| Lebonheur Children's Medical Center | |
| Memphis, Tennessee, United States, 38103 | |
| United States, Texas | |
| Univ. of Texas Southwestern Medical Center | |
| Dallas, Texas, United States, 75390 | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| Children's Hospital and Regional Medical Center | |
| Seattle, Washington, United States, 98105 | |
| Australia, South Australia | |
| University Dept. of Paediatrics, Women's and Children's Hospital | |
| North Adelaide, South Australia, Australia, 5006 | |
| Australia, Victoria | |
| Royal Children's Hospital, Murdoch Children's Research Institute | |
| Parkville, Victoria, Australia, 3052 | |
| Australia, Western Australia | |
| University of Western Australia | |
| Perth, Western Australia, Australia, 6014 | |
| Canada, Alberta | |
| University of Alberta | |
| Edmonton, Alberta, Canada, T6G 2J3 | |
| Canada, Manitoba | |
| Univ. of Mannitoba | |
| Winnipeg, Manitoba, Canada, R3E 3P4 | |
| Canada, Nova Scotia | |
| IWK Health Centre | |
| Halifax, Nova Scotia, Canada, B3K 6R8 | |
| Canada, Ontario | |
| The Hospital for Sick Children | |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Italy | |
| Institute of Pediatrics, University of Milan | |
| Milan, Italy, 20122 | |
Sponsors and Collaborators
MedImmune LLC
Investigators
| Study Director: | Margarita Gomez, M.D. | MedImmune LLC |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00192439 History of Changes |
| Other Study ID Numbers: | MI-CP096 |
| Study First Received: | September 12, 2005 |
| Last Updated: | May 4, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Respiration Disorders Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013