Novel Influenza A (H1N1) Surveillance Registry

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT01046331
First received: January 8, 2010
Last updated: November 9, 2010
Last verified: November 2010
  Purpose

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
Novel Influenza A
H1N1
Influenza

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Novel Influenza A (H1N1) Surveillance Registry

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Enrollment: 894
Study Start Date: October 2009
Study Completion Date: October 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046331

  Hide Study Locations
Locations
United States, Alaska
Alaska Native Medical Center
Anchorage, Alaska, United States
The Children's Hospital at Providence
Anchorage, Alaska, United States
United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States
United States, Arkansas
Arkansas Children's Hiospital
Little Rock, Arkansas, United States
United States, California
University of San Francisco-Fresno Medical Center
Fresno, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Children's Hospital and Research Center Oakland
Oakland, California, United States
Children's Hospital of Orange County
Orange, California, United States
University of California, Davis Medical Center
Sacramento, California, United States
UCSF-San Francisco General Hospital
San Francisco, California, United States
UCSF-Moffitt Hospital
San Francisco, California, United States
University of California, San Francisco (UCSF)-Moffitt Hospital
San Francisco, California, United States
UCSF Children's Medical Center
San Francisco, California, United States
United States, Colorado
Denver's Children Hospital
Aurora, Colorado, United States
Centura St. Anthony Central Hospital
Denver, Colorado, United States
Denver Health Medical Center
Denver, Colorado, United States
Rose Medical Center
Denver, Colorado, United States
University of Colorado Health Sciences Center
Denver, Colorado, United States
United States, Connecticut
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Yale-New Haven Children's Hospital
New Haven, Connecticut, United States
United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States
Washington Hospital Center
Washington DC, District of Columbia, United States
United States, Florida
Mayo Clinic at Jacksonville
Jacksonville, Florida, United States
Holt'z Children's Hospital
Miami, Florida, United States
Miami Children's Hospital
Miami, Florida, United States
United States, Georgia
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States
United States, Hawaii
Kapi'olani Center for Women and Children
Honolulu, Hawaii, United States
United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States
United States, Kentucky
Kosair Children's Hospital
Louisville, Kentucky, United States
United States, Louisiana
Earl K. Long Medical Center
Baton Rouge, Louisiana, United States
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Medical Center of Louisiana
New Orleans, Louisiana, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Union Memorial Hospital
Baltimore, Maryland, United States
University of Maryland Shock Trauma Center
Baltimore, Maryland, United States
Johns Hopkins Children's Center
Baltimore, Maryland, United States
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Baystate Medical Center
Springfield, Massachusetts, United States
United States, Michigan
Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States
United States, Minnesota
University of Minnesota Children's Hospital
Minneapolis, Minnesota, United States
Children's Hospital and Clinics of Minnesota
Minneapolis, Minnesota, United States
St. Mary's Hospital, Mayo Clinic
Rochester, Minnesota, United States
Rochester Methodist Hospital
Rochester, Minnesota, United States
United States, Missouri
SSM Cardinal Glennon Children's Medical Center
St. Louis, Missouri, United States
St. Louis Children's Hospital
St. Louis, Missouri, United States
United States, Nebraska
Children's Hospital of Nebraska
Omaha, Nebraska, United States
United States, New Hampshire
Darthmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
United States, New York
Children's Hospital of Montefiore
Bronx, New York, United States
University of Rochester Medical Center
Rocherster, New York, United States
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States
Durham Regional Medical Center
Durham, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Duke University Children's Hospital
Durham, North Carolina, United States
Wesley Long Community Hospital
Greensboro, North Carolina, United States
Moses Cone Health System
Greensboro, North Carolina, United States
Wake Forest University Baptist Medical Center
Winston Salem, North Carolina, United States
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Nationwide Children' Hospital
Columbus, Ohio, United States
United States, Oklahoma
Children's Hospital at St. Francis
Tulsa, Oklahoma, United States
United States, Oregon
Doernbecher Children's Hospital
Portland, Oregon, United States
United States, Pennsylvania
Penn State Children's Hospital
Hershey, Pennsylvania, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Monroe Carell Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
United States, Texas
Dell Children's Medical Center of Central Texas
Austin, Texas, United States
University of Texas Southwestern Children's Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
United States, Utah
Intermountain Medical Center
Murray, Utah, United States
McKay-Dee Hospital
Ogden, Utah, United States
Utah Valley Regional Medical Center
Provo, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
Primary Children's Medical Center
Salt Lake City, Utah, United States
United States, Virginia
University of Virginia Medical Center
Charlottesville, Virginia, United States
University of Virginia Children's Medical Center
Charlottesville, Virginia, United States
United States, Washington
Providence Hospital
Everett, Washington, United States
University of Washington
Seattle, Washington, United States
Seattle Children's Hospital
Seattle, Washington, United States
Harborview Medical Center
Seattle, Washington, United States
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Sponsors and Collaborators
Investigators
Principal Investigator: B. Taylor Thompson, MD Massachusetts General Hospital
Principal Investigator: Adrienne G Randolph, MD, MSc Children's Hospital Boston
Principal Investigator: Todd W Rice, MD, MSc Vanderbilt University
  More Information

Additional Information:
No publications provided

Responsible Party: Andrea Harabin, National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT01046331     History of Changes
Other Study ID Numbers: 688, N01HR056179, HSN268200536179C
Study First Received: January 8, 2010
Last Updated: November 9, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014