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Novel Influenza A (H1N1) Surv...

Novel Influenza A (H1N1) Surveillance Registry

Last Updated: 2016-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

894 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Novel Influenza A H1N1 Influenza

Study Design

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Observational Model Type

COHORT

Study Groups

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Adult H1N1

Patients admitted to adult ICU with confirmed or suspected H1N1 Influence infection

No interventions assigned to this group

Pediatric H1N1

Patients admitted to pediatric ICU with confirmed or suspected H1N1 Influenza infection

No interventions assigned to this group

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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National Heart, Lung, and Blood Institute (NHLBI)

Principal Investigators

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B. Taylor Thompson, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Adrienne G Randolph, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Todd W Rice, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

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Alaska Native Medical Center

Anchorage, Alaska, United States

Site Status

The Children's Hospital at Providence

Anchorage, Alaska, United States

Site Status

Phoenix Children's Hospital

Phoenix, Arizona, United States

Site Status

Arkansas Children's Hiospital

Little Rock, Arkansas, United States

Site Status

University of San Francisco-Fresno Medical Center

Fresno, California, United States

Site Status

Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status

Children's Hospital and Research Center Oakland

Oakland, California, United States

Site Status

Children's Hospital of Orange County

Orange, California, United States

Site Status

University of California, Davis Medical Center

Sacramento, California, United States

Site Status

UCSF Children's Medical Center

San Francisco, California, United States

Site Status

UCSF-Moffitt Hospital

San Francisco, California, United States

Site Status

UCSF-San Francisco General Hospital

San Francisco, California, United States

Site Status

University of California, San Francisco (UCSF)-Moffitt Hospital

San Francisco, California, United States

Site Status

Denver's Children Hospital

Aurora, Colorado, United States

Site Status

Centura St. Anthony Central Hospital

Denver, Colorado, United States

Site Status

Denver Health Medical Center

Denver, Colorado, United States

Site Status

Rose Medical Center

Denver, Colorado, United States

Site Status

University of Colorado Health Sciences Center

Denver, Colorado, United States

Site Status

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Site Status

Yale-New Haven Children's Hospital

New Haven, Connecticut, United States

Site Status

Children's National Medical Center

Washington D.C., District of Columbia, United States

Site Status

Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Mayo Clinic at Jacksonville

Jacksonville, Florida, United States

Site Status

Holt'z Children's Hospital

Miami, Florida, United States

Site Status

Miami Children's Hospital

Miami, Florida, United States

Site Status

Children's Healthcare of Atlanta at Egleston

Atlanta, Georgia, United States

Site Status

Kapi'olani Center for Women and Children

Honolulu, Hawaii, United States

Site Status

Children's Memorial Hospital

Chicago, Illinois, United States

Site Status

Kosair Children's Hospital

Louisville, Kentucky, United States

Site Status

Earl K. Long Medical Center

Baton Rouge, Louisiana, United States

Site Status

Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, United States

Site Status

Medical Center of Louisiana

New Orleans, Louisiana, United States

Site Status

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Site Status