Clinical trial NCT01046331: Novel Influenza A (H1N1) Surveillance Registry
Official title: Novel Influenza A (H1N1) Surveillance Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Novel Influenza A
H1N1
Influenza
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2010-01-12
Enrollment: 894
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects admitted to adult or pediatric ICUs with suspected or confirmed Novel H1N1 Influenza infection.

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.


Eligibility 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

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