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
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01046331
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Hide Study LocationsLocations
| 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 May 16, 2013