A Study To Evaluate Influence In Pediatric Intensive Care Patients
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 21-002814
About this study
The purpose of this study is to evaluate the immunobiology of influenza virus-related critical illness in young hosts.
Pediatric Intensive Care Influenza Study #2 (PICFLU2) is a multiyear, multicenter prospective observational study in patients aged ≤ 21 years hospitalized in pediatric Intensive Care Units (PICUs) and Stepdown (or intermediate) Care Units (SDUs) in the US. designed
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Admission to PICU or SDU at any point during illness due to severity (not due to bed availability).
- ≤ 21 years old on admission.
- Influenza-associated LRTI:
- Positive influenza test (rapid antigen, DFA or PCR) ;and
- > 1 sign of acute respiratory illness: cough, shortness of breath, tachypnea or retractions, invasive or non-invasive mechanical ventilation, need for FiO2 to maintain SpO2 >92%, pulmonary infiltrate or hyperinflation on chest imaging.
- At least 1 parent or legal guardian able and willing to provide permission.
Exclusion Criteria:
- Previous enrollment in this study during the current season.
- Hospital acquired influenza infection as determined by site hospital infection control experts.
- Pre-existing conditions that are known risk factors for severe influenza infection (with the exception of asthma or reactive airways disease (RAD). Exclusions include:
- Chronic pulmonary (except asthma/RAD) or upper airway disorders;
- History of prematurity in patients < 1 year of age;
- Known immune disorders;
- Cardiac disease with compromise requiring medications or alterations in activities;
- Neurologic disorders impairing respiratory muscle strength or secretion management;
- Sickle cell disease;
- Complex genetic disorders impairing multiple organ systems; AND
- Metabolic disorders that may be worsened by infection including diabetes mellitus.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Emily Levy, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available