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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00369759
Other study ID # MI-MA133
Secondary ID
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


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
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