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Novel Influenza A (H1N1) Surveillance Registry

This study has been completed.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI) Identifier:
First received: January 8, 2010
Last updated: April 13, 2016
Last verified: November 2010
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.

Novel Influenza A

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)
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


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.

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 identifier: NCT01046331

  Show 86 Study Locations
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: B. Taylor Thompson, MD Massachusetts General Hospital
Principal Investigator: Adrienne G Randolph, MD, MSc Boston Children’s Hospital
Principal Investigator: Todd W Rice, MD, MSc Vanderbilt University
  More Information

Additional Information:
Responsible Party: Andrea Harabin, National Heart, Lung, and Blood Institute (NHLBI) Identifier: NCT01046331     History of Changes
Other Study ID Numbers: 688
N01HR056179 ( Other Grant/Funding Number: NIH Contract Number )
HSN268200536179C ( Other Grant/Funding Number: NIH Contract Number )
Study First Received: January 8, 2010
Last Updated: April 13, 2016

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases processed this record on May 25, 2017