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Novel Influenza A (H1N1) Surveillance Registry

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01046331
First Posted: January 12, 2010
Last Update Posted: April 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
January 8, 2010
January 12, 2010
April 14, 2016
October 2009
April 2010   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01046331 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Novel Influenza A (H1N1) Surveillance Registry
Novel Influenza A (H1N1) Surveillance Registry
The demographic characteristics, clinical features, course, and outcomes of severe H1N1 influenza infection requiring intensive care have not been defined rigorously and systematically. While the majority of patients in early reports of critically ill novel influenza A (H1N1) have respiratory involvement, up to 10-20% may present with non-respiratory organ failures, such as shock, seizures, or acute renal failure. The burden of disease and resource utilization of these patients remains largely unknown. The purpose of this surveillance registry is to characterize the demographics, clinical features, outcomes, and resource utilization of patients with H1N1 influenza infection who require intensive care.
Not Provided
Observational
Observational Model: Cohort
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Non-Probability Sample
Subjects admitted to adult or pediatric ICUs with suspected or confirmed Novel H1N1 Influenza infection.
  • Novel Influenza A
  • H1N1
  • Influenza
Not Provided
  • Adult H1N1
    Patients admitted to adult ICU with confirmed or suspected H1N1 Influence infection
  • Pediatric H1N1
    Patients admitted to pediatric ICU with confirmed or suspected H1N1 Influenza infection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
894
October 2010
April 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Admission to an intensive care unit at a participating site with confirmed or suspected Novel H1N1 Influenza infection

Exclusion Criteria:

  • Influenza-like illness due to non-influenza disease and negative testing for influenza
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01046331
688
N01HR056179 ( Other Grant/Funding Number: NIH Contract Number )
HSN268200536179C ( Other Grant/Funding Number: NIH Contract Number )
No
Not Provided
Not Provided
Andrea Harabin, National Heart, Lung, and Blood Institute (NHLBI)
National Heart, Lung, and Blood Institute (NHLBI)
Not Provided
Principal Investigator: B. Taylor Thompson, MD Massachusetts General Hospital
Principal Investigator: Adrienne G Randolph, MD, MSc Boston Children’s Hospital
Principal Investigator: Todd W Rice, MD, MSc Vanderbilt University
National Heart, Lung, and Blood Institute (NHLBI)
November 2010