Novel Influenza A (H1N1) Surveillance Registry

April 13, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
894

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects admitted to adult or pediatric ICUs with suspected or confirmed Novel H1N1 Influenza infection.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Todd W Rice, MD, MSc, Vanderbilt University
  • Principal Investigator: B. Taylor Thompson, MD, Massachusetts General Hospital
  • Principal Investigator: Adrienne G Randolph, MD, MSc, Boston Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 688
  • N01HR056179 (Other Grant/Funding Number: NIH Contract Number)
  • HSN268200536179C (Other Grant/Funding Number: NIH Contract Number)

Plan for Individual participant data (IPD)

Study Data/Documents

  1. Individual Participant Data Set
    Information identifier: H1N1
    Information comments: 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.
  2. Study Forms

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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