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Novel Influenza A (H1N1) Surveillance Registry

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.
 
ClinicalTrials.gov Identifier: NCT01046331
Recruitment Status : Completed
First Posted : January 12, 2010
Last Update Posted : April 14, 2016
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Study Description
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Brief Summary:
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.

Condition or disease
Novel Influenza A H1N1 Influenza

Study Design
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Study Type : Observational
Actual Enrollment : 894 participants
Observational Model: Cohort
Official Title: Novel Influenza A (H1N1) Surveillance Registry
Study Start Date : October 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects admitted to adult or pediatric ICUs with suspected or confirmed Novel H1N1 Influenza infection.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01046331


Locations
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Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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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
More Information
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Additional Information:

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: H1N1
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.
Study Forms  This link exits the ClinicalTrials.gov site

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Responsible Party: Andrea Harabin, National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT01046331    
Other Study ID Numbers: 688
N01HR056179 ( Other Grant/Funding Number: NIH Contract Number )
HSN268200536179C ( Other Grant/Funding Number: NIH Contract Number )
First Posted: January 12, 2010    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: November 2010
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases