Viral INfections in the Young Lung- The VINYL Clinical Consortium (UG3/UH3 Clinical Trial Optional)

The objective of this program is to create a consortium of clinical sites that will perform deep phenotyping in 1500 babies, infants, and toddlers (0-2 years of age) with viral lower respiratory tract infections (LRTI) and hospitalized with acute bronchiolitis, pneumonia and/or pediatric acute respiratory distress syndrome (PARDS), and longitudinal follow up of participants for evidence of lung disease including asthma at age 4-5 years. Bronchiolitis, a condition unique to the young lung, is the leading cause of hospitalization for viral LRTI in 02-year-old children, including those born preterm. There are critical knowledge gaps in defining the condition, predicting its severity, and understanding the reasons for hospitalization, including the immature host respiratory immune response to viral infection, heterogeneity in response to different viruses, current interventions, significant practice variation in diagnosis and management and subsequent impact on lung health. To meet the need for deep phenotyping, identify appropriate subgroups, refine the diagnosis and management of these vulnerable patients during their hospitalization, and identify prognostic biomarkers for future airway and parenchymal disease, we propose the VINYL (Viral INfections in the Young Lung) clinical consortium, a pragmatic observational study, to perform deep phenotypic characterization of 1500 babies, infants and toddlers admitted to the pediatric floor and pediatric intensive care unit with viral LRTI. A longitudinal follow-up of participants after discharge using electronic health records and questionnaires and assessment of respiratory status at age 4-5 years will elucidate pulmonary outcomes from early viral LRTI, specifically asthma. Neurocognitive and general development, and sleep will also be assessed during follow up.

The objective of this program is to create a consortium of clinical sites that will perform deep phenotyping in 1500 babies, infants, and toddlers (0-2 years of age) with viral lower respiratory tract infections (LRTI) and hospitalized with acute bronchiolitis, pneumonia and/or pediatric acute respiratory distress syndrome (PARDS), and longitudinal follow up of participants for evidence of lung disease including asthma at age 4-5 years. Bronchiolitis, a condition unique to the young lung, is the leading cause of hospitalization for viral LRTI in 02-year-old children, including those born preterm. There are critical knowledge gaps in defining the condition, predicting its severity, and understanding the reasons for hospitalization, including the immature host respiratory immune response to viral infection, heterogeneity in response to different viruses, current interventions, significant practice variation in diagnosis and management and subsequent impact on lung health. To meet the need for deep phenotyping, identify appropriate subgroups, refine the diagnosis and management of these vulnerable patients during their hospitalization, and identify prognostic biomarkers for future airway and parenchymal disease, we propose the VINYL (Viral INfections in the Young Lung) clinical consortium, a pragmatic observational study, to perform deep phenotypic characterization of 1500 babies, infants and toddlers admitted to the pediatric floor and pediatric intensive care unit with viral LRTI. A longitudinal follow-up of participants after discharge using electronic health records and questionnaires and assessment of respiratory status at age 4-5 years will elucidate pulmonary outcomes from early viral LRTI, specifically asthma. Neurocognitive and general development, and sleep will also be assessed during follow up.

Other Eligible Applicants include the following:
Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Indian/Native American Tribal Governments (Other than Federally Recognized); Regional Organizations; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.