An Epidemiological Study to Evaluate the RSV-Associated Lower Respiratory Track in Infections in Infants
16. marts 2009 opdateret af: MedImmune LLC
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
- 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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
2048
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Arizona
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Phoenix, Arizona, Forenede Stater, 85008
- Maricopa Medical Center
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California
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Sylmar, California, Forenede Stater, 91342
- Olive View- UCLA Medical Center
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Colorado
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Denver, Colorado, Forenede Stater, 80218
- The Children's Hospital
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Delaware
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Wilmington, Delaware, Forenede Stater, 19803-3607
- Alfred I. DuPont Hospital for Children
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Wilmington, Delaware, Forenede Stater, 19803-3607
- Alfred J. Dupont Hospital for Children
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20010-2970
- Children's National Medical Center
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Florida
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Miami, Florida, Forenede Stater, 33155
- Miami Children's Hospital Research Institute
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Miami, Florida, Forenede Stater, 33136
- Batchelor Children's Institute
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Georgia
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Atlanta, Georgia, Forenede Stater, 30329
- Emory University
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Atlanta, Georgia, Forenede Stater, 30342
- Children's Healthcare of Atlanta
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Illinois
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Chicago, Illinois, Forenede Stater, 60614
- Children's Memorial Hospital
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536-0298
- University of Kentucky Chandler Medical Center/University of Kentucky Clinical Research
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Louisiana
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Shreveport, Louisiana, Forenede Stater, 71130
- Louisiana State University health Sciences Center
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Maryland
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Baltimore, Maryland, Forenede Stater, 21201
- University of Maryland
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Baltimore, Maryland, Forenede Stater, 21201
- Children's National Medical Center
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Michigan
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Detroit, Michigan, Forenede Stater, 48201
- Children's Hospital of Michigan
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Flint, Michigan, Forenede Stater, 48503
- Hurley Medical Center
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Mississippi
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Jackson, Mississippi, Forenede Stater, 39216
- University of Mississippi
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Missouri
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St. Louis, Missouri, Forenede Stater, 63110
- St. Louis Children's Hospital (Washington University)
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68178
- University of Nebraska Medical Center combined Divistion of Pediatric Infectious Disease
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New York
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Buffalo, New York, Forenede Stater, 14222
- Children's Hospital of Buffalo
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Syracuse, New York, Forenede Stater, 13202
- Upstate Medical University
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North Carolina
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Winston-Salem, North Carolina, Forenede Stater, 27157
- Wake Forest University Medical Center
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45229
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, Forenede Stater, 44106
- Case Western Reserve University
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Columbus, Ohio, Forenede Stater, 43205
- Columbus Children's Hospital - Nationwide Children's of Colombus
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Dayton, Ohio, Forenede Stater, 45404
- The Children's Medical Center of Dayton
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Oregon
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Portland, Oregon, Forenede Stater, 97239
- Doernbecher Children's Hospital Oregon Health Sciences University Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19140
- Temple University Children's Medical Center
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29425
- Medical University of SC
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Tennessee
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Memphis, Tennessee, Forenede Stater, 38103
- University of Tennesee, LeBonheur Children's Med. Center
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Texas
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Corpus Christi, Texas, Forenede Stater, 78411
- Driscoll Children's Hospital
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Dallas, Texas, Forenede Stater, 75390-9063
- University of Texas Southwestern Medical Center
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Dallas, Texas, Forenede Stater, 75390
- University of Texas, Southwestern Medical Center
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Temple, Texas, Forenede Stater, 76502
- Austin Children's Hospital
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Washington
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Seattle, Washington, Forenede Stater, 98105-0371
- Seattle Children's Hospital and Regional Medical Center
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Wisconsin
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Milwaukee, Wisconsin, Forenede Stater, 53226
- Medical College of Wisconsin
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Milwaukee, Wisconsin, Forenede Stater, 53326
- Medical College of Wisconsin
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
1 dag til 1 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Eligible subjects with RSV results.
Beskrivelse
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:
- 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 Criteria:
- Use of palivizumab or RSV-IGIV at any time prior to enrollment
- Participation in trials of investigational RSV prophylaxis or therapeutic agents
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
1
Bronchiolitis, pneumonia or Lower Respiratory Infection or LRI (Season 1: 2006-'07 and same for Season 2: 2007 - '08)
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No intervention; Epidemiological Study
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2
Bronchiolitis, pneumonia or Lower Respiratory Infection or LRI (Season 1: 2006-'07 and same for Season 2: 2007 - '08)
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No intervention; Epidemiological Study
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3
Bronchiolitis, pneumonia or Lower Respiratory Infection or LRI (Season 1: 2006-'07 and same for Season 2: 2007 - '08)
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No intervention; Epidemiological Study
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Measuring the incidence of RSV-associated, LRI or apnea among infants <1 yr. old presenting the Emergency Dept. during shoulder months.
Tidsramme: July 2008
|
July 2008
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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)
Tidsramme: July 2008
|
July 2008
|
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Societal burden(no. of days lost from work by parent/guardian) for infants through 14 days after index ED visit and through hospital discharge.
Tidsramme: July 2008
|
July 2008
|
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Comparison of rates of RSV-associated LRI or apnea during the peak periods and between shoulder and peak periods.
Tidsramme: July 2008
|
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.
Tidsramme: July 2008
|
July 2008
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Jessie R. Groothuis, M.D., MedImmune LLC
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2006
Primær færdiggørelse (Faktiske)
1. juli 2008
Studieafslutning (Faktiske)
1. september 2008
Datoer for studieregistrering
Først indsendt
24. august 2006
Først indsendt, der opfyldte QC-kriterier
25. august 2006
Først opslået (Skøn)
29. august 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
17. marts 2009
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. marts 2009
Sidst verificeret
1. marts 2009
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MI-MA133
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .