An Epidemiological Study to Evaluate the RSV-Associated Lower Respiratory Track in Infections in Infants

Completed

Conditions studied: Respiratory Infections, Bronchiolitis, Pneumonia, Apnea

In brief

The primary objective of this study is to describe the incidence of RSV-associated LRI among infants \<1 year of age presenting to the ED during selected shoulder months.

Key facts

Study ID

NCT00369759

Run by

MedImmune LLC

People needed

2048

Starts

2006-09-01

Expected to finish

2008-09-01

Last updated by the study team

2009-03-17

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent from parent/guardian to participate in this study
• Male and female infants <1 year of age (child must be entered before his/her 1st birthday)
• Physician diagnosis of either a) acute LRI or b) apnea below:
• A) Acute LRI, defined as:
• Medical diagnosis of bronchiolitis or pneumonia, or
• In the absence of either of these diagnoses, LRI will be determined by the investigator after review of the medical record and must include at least one of the following:
• Retractions
• Wheezing
• Rales or crackles
• The presence of a new infiltrate, if a chest X-ray is available, which must be diagnosed by the ED physician or radiologist
• B) Apnea, defined as either:
• Cessation of breathing for >20 seconds by history or observation, or
• Cessation of breathing for any length of time if accompanied by cyanosis or pallor, bradycardia as detected by a monitor, or
• ED primary diagnosis of apnea
• Parent/guardian has the ability and willingness to be available for a follow-up interview by telephone

You may not qualify if…

• Use of palivizumab or RSV-IGIV at any time prior to enrollment
• Participation in trials of investigational RSV prophylaxis or therapeutic agents

Where it is running

• Maricopa Medical Center — Phoenix, Arizona, United States
• Olive View- UCLA Medical Center — Sylmar, California, United States
• The Children's Hospital — Denver, Colorado, United States
• Alfred I. duPont Hospital for Children — Wilmington, Delaware, United States
• Alfred J. Dupont Hospital for Children — Wilmington, Delaware, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Batchelor Children's Institute — Miami, Florida, United States
• Miami Children's Hospital Research Institute — Miami, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Children's Memorial Hospital — Chicago, Illinois, United States
• University of Kentucky Chandler Medical Center/University of Kentucky Clinical Research — Lexington, Kentucky, United States
• Louisiana State University Health Sciences Center — Shreveport, Louisiana, United States
• Children's National Medical Center — Baltimore, Maryland, United States
• University of Maryland — Baltimore, Maryland, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• Hurley Medical Center — Flint, Michigan, United States
• University of Mississippi — Jackson, Mississippi, United States
• St. Louis Children's Hospital (Washington University) — St Louis, Missouri, United States
• University of Nebraska Medical Center combined Divistion of Pediatric Infectious Disease — Omaha, Nebraska, United States
• Children's Hospital of Buffalo — Buffalo, New York, United States
• Upstate Medical University — Syracuse, New York, United States
• Wake Forest University Medical Center — Winston-Salem, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Case Western Reserve University — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.