Study to Evaluate the Human Infection of the Lower Respiratory Tract in Children at High Risk

This study has been completed.
Sponsor:
Information provided by:
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT00192439
First received: September 12, 2005
Last updated: May 4, 2007
Last verified: May 2007
  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
Time Perspective: Cross-Sectional
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

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Enrollment: 1500
Study Start Date: December 2003
Study Completion Date: December 2006
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.
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00192439

  Hide Study Locations
Locations
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:
Respiratory Tract Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on October 01, 2014