An Epidemiological Study to Evaluate the RSV-Associated Lower Respiratory Track in Infections in Infants
16 mars 2009 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
- 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.
Studietyp
Observationell
Inskrivning (Faktisk)
2048
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Arizona
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Phoenix, Arizona, Förenta staterna, 85008
- Maricopa Medical Center
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California
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Sylmar, California, Förenta staterna, 91342
- Olive View- UCLA Medical Center
-
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Colorado
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Denver, Colorado, Förenta staterna, 80218
- The Children's Hospital
-
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Delaware
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Wilmington, Delaware, Förenta staterna, 19803-3607
- Alfred I. DuPont Hospital for Children
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Wilmington, Delaware, Förenta staterna, 19803-3607
- Alfred J. Dupont Hospital for Children
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District of Columbia
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Washington, District of Columbia, Förenta staterna, 20010-2970
- Children's National Medical Center
-
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Florida
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Miami, Florida, Förenta staterna, 33155
- Miami Children's Hospital Research Institute
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Miami, Florida, Förenta staterna, 33136
- Batchelor Children's Institute
-
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Georgia
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Atlanta, Georgia, Förenta staterna, 30329
- Emory University
-
Atlanta, Georgia, Förenta staterna, 30342
- Children's Healthcare of Atlanta
-
-
Illinois
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Chicago, Illinois, Förenta staterna, 60614
- Children's Memorial Hospital
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Kentucky
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Lexington, Kentucky, Förenta staterna, 40536-0298
- University of Kentucky Chandler Medical Center/University of Kentucky Clinical Research
-
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Louisiana
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Shreveport, Louisiana, Förenta staterna, 71130
- Louisiana State University Health Sciences Center
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Maryland
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Baltimore, Maryland, Förenta staterna, 21201
- University of Maryland
-
Baltimore, Maryland, Förenta staterna, 21201
- Children's National Medical Center
-
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Michigan
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Detroit, Michigan, Förenta staterna, 48201
- Children's Hospital of Michigan
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Flint, Michigan, Förenta staterna, 48503
- Hurley Medical Center
-
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Mississippi
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Jackson, Mississippi, Förenta staterna, 39216
- University of Mississippi
-
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Missouri
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St. Louis, Missouri, Förenta staterna, 63110
- St. Louis Children's Hospital (Washington University)
-
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Nebraska
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Omaha, Nebraska, Förenta staterna, 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, Förenta staterna, 14222
- Children's Hospital of Buffalo
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Syracuse, New York, Förenta staterna, 13202
- Upstate Medical University
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North Carolina
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Winston-Salem, North Carolina, Förenta staterna, 27157
- Wake Forest University Medical Center
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45229
- Cincinnati Children's Hospital Medical Center
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Cleveland, Ohio, Förenta staterna, 44106
- Case Western Reserve University
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Columbus, Ohio, Förenta staterna, 43205
- Columbus Children's Hospital - Nationwide Children's of Colombus
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Dayton, Ohio, Förenta staterna, 45404
- The Children's Medical Center of Dayton
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Oregon
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Portland, Oregon, Förenta staterna, 97239
- Doernbecher Children's Hospital Oregon Health Sciences University Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19140
- Temple University Children's Medical Center
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South Carolina
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Charleston, South Carolina, Förenta staterna, 29425
- Medical University of SC
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Tennessee
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Memphis, Tennessee, Förenta staterna, 38103
- University of Tennesee, LeBonheur Children's Med. Center
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Texas
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Corpus Christi, Texas, Förenta staterna, 78411
- Driscoll Children's Hospital
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Dallas, Texas, Förenta staterna, 75390-9063
- University of Texas Southwestern Medical Center
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Dallas, Texas, Förenta staterna, 75390
- University of Texas, Southwestern Medical Center
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Temple, Texas, Förenta staterna, 76502
- Austin Children's Hospital
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Washington
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Seattle, Washington, Förenta staterna, 98105-0371
- Seattle Children's Hospital and Regional Medical Center
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Wisconsin
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Milwaukee, Wisconsin, Förenta staterna, 53226
- Medical College of Wisconsin
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Milwaukee, Wisconsin, Förenta staterna, 53326
- Medical College of Wisconsin
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
1 dag till 1 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Eligible subjects with RSV results.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
1
Bronchiolitis, pneumonia or Lower Respiratory Infection or LRI (Season 1: 2006-'07 and same for Season 2: 2007 - '08)
|
No intervention; Epidemiological Study
|
|
2
Bronchiolitis, pneumonia or Lower Respiratory Infection or LRI (Season 1: 2006-'07 and same for Season 2: 2007 - '08)
|
No intervention; Epidemiological Study
|
|
3
Bronchiolitis, pneumonia or Lower Respiratory Infection or LRI (Season 1: 2006-'07 and same for Season 2: 2007 - '08)
|
No intervention; Epidemiological Study
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Measuring the incidence of RSV-associated, LRI or apnea among infants <1 yr. old presenting the Emergency Dept. during shoulder months.
Tidsram: July 2008
|
July 2008
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
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)
Tidsram: July 2008
|
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.
Tidsram: July 2008
|
July 2008
|
|
Comparison of rates of RSV-associated LRI or apnea during the peak periods and between shoulder and peak periods.
Tidsram: 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.
Tidsram: July 2008
|
July 2008
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Jessie R. Groothuis, M.D., MedImmune LLC
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 september 2006
Primärt slutförande (Faktisk)
1 juli 2008
Avslutad studie (Faktisk)
1 september 2008
Studieregistreringsdatum
Först inskickad
24 augusti 2006
Först inskickad som uppfyllde QC-kriterierna
25 augusti 2006
Första postat (Uppskatta)
29 augusti 2006
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
17 mars 2009
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 mars 2009
Senast verifierad
1 mars 2009
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MI-MA133
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .