Clinical trial NCT00369759: An Epidemiological Study to Evaluate the RSV-Associated Lower Respiratory Track in Infections in Infants
Official title: An Epidemiological Study to Evaluate the Seasonality of Respiratory Syncytial Virus-Associated-Lower Respiratory Tract Infections (LRI) or Apnea in Infants in the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Infections
Bronchiolitis
Pneumonia
Apnea
Keywords: Acute Lower Respiratory Infection
Retractions
Bronchiolitis or pneumonia
Wheezing
Rales
Crackles
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2006-08-29
Enrollment: 2048
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible subjects with RSV results.

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. The total number of events will also be described.
* To characterize the clinical outcomes and demographic data of infants presenting to the ED with RSV-associated LRI or apnea
* To characterize the social burden (in the form of number of days lost from work by parent/ guardian) for these infants through 14 days after the index ED visit and through hospital discharge will also be described.
* Based on a sample of cases collected in a cohort of patients enrolled at or near the peak of RSV disease during the traditional season, a comparison of the rate of RSV between shoulder and peak periods will be described.
* To describe the overall rates of RSV-associated LRI or apnea based on the general ED statistics collected during the entire study period.

Eligibility criteria: Inclusion Criteria:

* 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:

1. Medical diagnosis of bronchiolitis or pneumonia, or
2. 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:

1. Cessation of breathing for \>20 seconds by history or observation, or
2. Cessation of breathing for any length of time if accompanied by cyanosis or pallor, bradycardia as detected by a monitor, or
3. ED primary diagnosis of apnea

   * Parent/guardian has the ability and willingness to be available for a follow-up interview by telephone

Exclusion Criteria:

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

Primary outcomes:
measure: Measuring the incidence of RSV-associated, LRI or apnea among infants <1 yr. old presenting the Emergency Dept. during shoulder months.
timeFrame: July 2008
Secondary outcomes:
measure: Clinical outcome of infants at Emergency Dept. with RSV-associated LRI or apnea.(hospital admission, 23 hr.-observations,no. of outpatient and/or urgent care visits,ICU,mechanical ventilation,supplemental oxygen use, meds,admission rate)
timeFrame: July 2008
measure: Societal burden(no. of days lost from work by parent/guardian) for infants through 14 days after index ED visit and through hospital discharge.
timeFrame: July 2008
measure: Comparison of rates of RSV-associated LRI or apnea during the peak periods and between shoulder and peak periods.
timeFrame: July 2008
measure: Overall rates of RSV-associated LRI or apnea based on general ED statistics collected during the entire study period, including outside recruitment periods.
timeFrame: July 2008
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Maricopa Medical Center
state: Arizona
city: Sylmar
country: United States
facility: Olive View- UCLA Medical Center
state: California
city: Denver
country: United States
facility: The Children's Hospital
state: Colorado
city: Wilmington
country: United States
facility: Alfred I. duPont Hospital for Children
state: Delaware
city: Wilmington
country: United States
facility: Alfred J. Dupont Hospital for Children
state: Delaware
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Miami
country: United States
facility: Batchelor Children's Institute
state: Florida
city: Miami
country: United States
facility: Miami Children's Hospital Research Institute
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Children's Memorial Hospital
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center/University of Kentucky Clinical Research
state: Kentucky
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Center
state: Louisiana
city: Baltimore
country: United States
facility: Children's National Medical Center
state: Maryland
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi
state: Mississippi
city: St. Louis
country: United States
facility: St. Louis Children's Hospital (Washington University)
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center combined Divistion of Pediatric Infectious Disease
state: Nebraska
city: Buffalo
country: United States
facility: Children's Hospital of Buffalo
state: New York
city: Syracuse
country: United States
facility: Upstate Medical University
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Columbus
country: United States
facility: Columbus Children's Hospital - Nationwide Children's of Colombus
state: Ohio
city: Dayton
country: United States
facility: The Children's Medical Center of Dayton
state: Ohio
city: Portland
country: United States
facility: Doernbecher Children's Hospital Oregon Health Sciences University Hospital
state: Oregon
city: Philadelphia
country: United States
facility: Temple University Children's Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of SC
state: South Carolina
city: Memphis
country: United States
facility: University of Tennesee, LeBonheur Children's Med. Center
state: Tennessee
city: Corpus Christi
country: United States
facility: Driscoll Children's Hospital
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Dallas
country: United States
facility: University of Texas, Southwestern Medical Center
state: Texas
city: Temple
country: United States
facility: Austin Children's Hospital
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital and Regional Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: MedImmune LLC
name: Jessie R. Groothuis, M.D.
role: STUDY_DIRECTOR
References: