Status:
COMPLETED
An Epidemiological Study to Evaluate the RSV-Associated Lower Respiratory Track in Infections in Infants
Lead Sponsor:
MedImmune LLC
Conditions:
Respiratory Infections
Bronchiolitis
Eligibility:
All Genders
1-12 years
Brief Summary
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.
Detailed Description
* The primary objective of this study is to describe the incidence of RSV-associated LRI or apnea (% RSV positive) among infants \<1 year of age presenting to the ED during selected shoulder months. T...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Use of palivizumab or RSV-IGIV at any time prior to enrollment
- Participation in trials of investigational RSV prophylaxis or therapeutic agents
Key Trial Info
Start Date :
September 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
2048 Patients enrolled
Trial Details
Trial ID
NCT00369759
Start Date
September 1 2006
End Date
September 1 2008
Last Update
March 17 2009
Active Locations (38)
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1
Maricopa Medical Center
Phoenix, Arizona, United States, 85008
2
Olive View- UCLA Medical Center
Sylmar, California, United States, 91342
3
The Children's Hospital
Denver, Colorado, United States, 80218
4
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States, 19803-3607