Pediatric Intensive Care Influenza Study #2
C
Courtney Rowan, MD
Primary Investigator
Enrolling By Invitation
21 years and younger
All
Phase
N/A
10 participants needed
1 Location
Brief description of study
Aim 1: To define important clinical outcomes in children with severe influenza LRTI and identify clinical and laboratory biomarkers for risk stratification in future immunomodulatory clinical trials.
Aim 2: To identify how pre-existing immunity to influenza virus protects against life-threatening disease and influences viral shedding and disease severity.
Aim 3: To identify common and rare gene variants influencing anti-influenza immunity and/or viral containment that explains host susceptibility to severe influenza infection or its outcome.
Detailed description of study
Researchers will swab participants to confirm that they have influenza. Researchers will then ask the participant or participant's guardians for health information. Researchers will review the participant's chart and record relevant health information. Researchers may swab the participant a few more times over the participant's hospital stay. Researchers will perform lab tests on the swabbed samples.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Influenza, Riley
-
Age: - 21 Years
-
Gender: All
Inclusion Criteria:
- Admission to PICU or SDU at any point during illness due to severity
- 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.
Updated on
13 Sep 2024.
Study ID: 10232, PICU-BCH-PICFLU2
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