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

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

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.

Study Overview

• Status: Completed
• Conditions: Apnea; Pneumonia; Bronchiolitis; Respiratory Infections
• Intervention / Treatment: Other: Emergency Dept. Subjects with LRI or Apnea

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.

• Study Type: Observational
• Enrollment (Actual): 2048

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85008
      • Maricopa Medical Center
  • California
    • Sylmar, California, United States, 91342
      • Olive View- UCLA Medical Center
  • Colorado
    • Denver, Colorado, United States, 80218
      • The Children's Hospital
  • Delaware
    • Wilmington, Delaware, United States, 19803-3607
      • Alfred I. DuPont Hospital for Children
    • Wilmington, Delaware, United States, 19803-3607
      • Alfred J. Dupont Hospital for Children
  • District of Columbia
    • Washington, District of Columbia, United States, 20010-2970
      • Children's National Medical Center
  • Florida
    • Miami, Florida, United States, 33155
      • Miami Children's Hospital Research Institute
    • Miami, Florida, United States, 33136
      • Batchelor Children's Institute
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Emory University
    • Atlanta, Georgia, United States, 30342
      • Children's Healthcare of Atlanta
  • Illinois
    • Chicago, Illinois, United States, 60614
      • Children's Memorial Hospital
  • Kentucky
    • Lexington, Kentucky, United States, 40536-0298
      • University of Kentucky Chandler Medical Center/University of Kentucky Clinical Research
  • Louisiana
    • Shreveport, Louisiana, United States, 71130
      • Louisiana State University Health Sciences Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
    • Baltimore, Maryland, United States, 21201
      • Children's National Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Children's Hospital of Michigan
    • Flint, Michigan, United States, 48503
      • Hurley Medical Center
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • University of Mississippi
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • St. Louis Children's Hospital (Washington University)
  • Nebraska
    • Omaha, Nebraska, United States, 68178
      • University of Nebraska Medical Center combined Divistion of Pediatric Infectious Disease
  • New York
    • Buffalo, New York, United States, 14222
      • Children's Hospital of Buffalo
    • Syracuse, New York, United States, 13202
      • Upstate Medical University
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University
    • Columbus, Ohio, United States, 43205
      • Columbus Children's Hospital - Nationwide Children's of Colombus
    • Dayton, Ohio, United States, 45404
      • The Children's Medical Center of Dayton
  • Oregon
    • Portland, Oregon, United States, 97239
      • Doernbecher Children's Hospital Oregon Health Sciences University Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Children's Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University Of SC
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • University of Tennesee, LeBonheur Children's Med. Center
  • Texas
    • Corpus Christi, Texas, United States, 78411
      • Driscoll Children's Hospital
    • Dallas, Texas, United States, 75390-9063
      • University of Texas Southwestern Medical Center
    • Dallas, Texas, United States, 75390
      • University of Texas, Southwestern Medical Center
    • Temple, Texas, United States, 76502
      • Austin Children's Hospital
  • Washington
    • Seattle, Washington, United States, 98105-0371
      • Seattle Children's Hospital and Regional Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin
    • Milwaukee, Wisconsin, United States, 53326
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Eligible subjects with RSV results.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; Bronchiolitis, pneumonia or Lower Respiratory Infection or LRI (Season 1: 2006-'07 and same for Season 2: 2007 - '08)	Other: Emergency Dept. Subjects with LRI or Apnea; No intervention; Epidemiological Study
2; Bronchiolitis, pneumonia or Lower Respiratory Infection or LRI (Season 1: 2006-'07 and same for Season 2: 2007 - '08)	Other: Emergency Dept. Subjects with LRI or Apnea; No intervention; Epidemiological Study
3; Bronchiolitis, pneumonia or Lower Respiratory Infection or LRI (Season 1: 2006-'07 and same for Season 2: 2007 - '08)	Other: Emergency Dept. Subjects with LRI or Apnea; No intervention; Epidemiological Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measuring the incidence of RSV-associated, LRI or apnea among infants <1 yr. old presenting the Emergency Dept. during shoulder months.	July 2008

Secondary Outcome Measures

Outcome Measure	Time Frame
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)	July 2008
Societal burden(no. of days lost from work by parent/guardian) for infants through 14 days after index ED visit and through hospital discharge.	July 2008
Comparison of rates of RSV-associated LRI or apnea during the peak periods and between shoulder and peak periods.	July 2008
Overall rates of RSV-associated LRI or apnea based on general ED statistics collected during the entire study period, including outside recruitment periods.	July 2008

Collaborators and Investigators

• Sponsor: MedImmune LLC
• Investigators: Study Director: Jessie R. Groothuis, M.D., MedImmune LLC

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: August 24, 2006
• First Submitted That Met QC Criteria: August 25, 2006
• First Posted (Estimate): August 29, 2006

Study Record Updates

• Last Update Posted (Estimate): March 17, 2009
• Last Update Submitted That Met QC Criteria: March 16, 2009
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Keywords: Wheezing; Rales; Crackles; Acute Lower Respiratory Infection; Retractions; Bronchiolitis or pneumonia
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Infections; Communicable Diseases; Pneumonia; Respiratory Tract Infections; Bronchiolitis
• Other Study ID Numbers: MI-MA133