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

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00369759
• Other study ID #: MI-MA133
• Status: Completed
• Phase: N/A
• First received: August 24, 2006
• Last updated: March 16, 2009
• Start date: September 2006
• Est. completion date: September 2008

Study information

• Verified date: March 2009
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2048
• Est. completion date: September 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Months

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea
• Bronchiolitis
• Communicable Diseases
• Infection
• Pneumonia
• Respiratory Infections
• Respiratory Tract Infections

Intervention

Other:
• Emergency Dept. Subjects with LRI or Apnea
No intervention; Epidemiological Study

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Emory University	Atlanta	Georgia
United States	Children's National Medical Center	Baltimore	Maryland
United States	University of Maryland	Baltimore	Maryland
United States	Children's Hospital of Buffalo	Buffalo	New York
United States	Medical University of SC	Charleston	South Carolina
United States	Children's Memorial Hospital	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Case Western Reserve University	Cleveland	Ohio
United States	Columbus Children's Hospital - Nationwide Children's of Colombus	Columbus	Ohio
United States	Driscoll Children's Hospital	Corpus Christi	Texas
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	University of Texas, Southwestern Medical Center	Dallas	Texas
United States	The Children's Medical Center of Dayton	Dayton	Ohio
United States	The Children's Hospital	Denver	Colorado
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	University of Kentucky Chandler Medical Center/University of Kentucky Clinical Research	Lexington	Kentucky
United States	University of Tennesee, LeBonheur Children's Med. Center	Memphis	Tennessee
United States	Batchelor Children's Institute	Miami	Florida
United States	Miami Children's Hospital Research Institute	Miami	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Nebraska Medical Center combined Divistion of Pediatric Infectious Disease	Omaha	Nebraska
United States	Temple University Children's Medical Center	Philadelphia	Pennsylvania
United States	Maricopa Medical Center	Phoenix	Arizona
United States	Doernbecher Children's Hospital Oregon Health Sciences University Hospital	Portland	Oregon
United States	Seattle Children's Hospital and Regional Medical Center	Seattle	Washington
United States	Louisiana State University Health Sciences Center	Shreveport	Louisiana
United States	St. Louis Children's Hospital (Washington University)	St. Louis	Missouri
United States	Olive View- UCLA Medical Center	Sylmar	California
United States	Upstate Medical University	Syracuse	New York
United States	Austin Children's Hospital	Temple	Texas
United States	Children's National Medical Center	Washington	District of Columbia
United States	Alfred I. duPont Hospital for Children	Wilmington	Delaware
United States	Alfred J. Dupont Hospital for Children	Wilmington	Delaware
United States	Wake Forest University Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring the incidence of RSV-associated, LRI or apnea among infants <1 yr. old presenting the Emergency Dept. during shoulder months.		July 2008	No
Secondary	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	No
Secondary	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	No
Secondary	Comparison of rates of RSV-associated LRI or apnea during the peak periods and between shoulder and peak periods.		July 2008	No
Secondary	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	No