ASsessing and Predicting Infant RSV Effects and Severity (AsPIRES) Study

A prospective multi-year clinical translational study including three cohorts of term infants experiencing their first Respiratory Syncytial Virus (RSV) season. All infants are less than or equal to nine months of age at study entry. The three subject cohorts represent the full spectrum of RSV disease severity and include a birth cohort, a cohort of infants hospitalized for RSV disease and infants evaluated at ambulatory settings for RSV infection. All infants are followed longitudinally and evaluated at recognition of acute RSV infection and twice during convalescence. Innate and adaptive immune status are comprehensively measured in association with clinical, environmental, viral, and bacteriologic factors. Genome-wide expression is assessed in the nasal airways, and in sorted peripheral blood lymphocytes. The study goal is to Identify host responses to RSV infection and factors associated with severe disease. ]]>
Inclusion criteria: Gestational age >=36 weeks and in good health at birth discharge Parent/guardian can provide informed consent Infant will be available for duration of the study Acute illness documented to be due to RSV infection (hospital cohort only) Born after the previous May 1st Exclusion criteria: Any infant eligible to receive RSV prophylaxis with Palivizumab Presence of underlying neuromuscular disorder (i.e., Down's syndrome, cerebral palsy) Immunosuppressive condition (i.e., HIV infection in mother) or use of immunosuppressive medications prior to RSV infection Presence of malignancy (i.e., Wilms tumor) Inability to contact for the duration of the study Any other condition deemed to place infant at higher risk for severe RSV infection (i.e., NICU transfer at birth, recurrent aspiration) Infants hospitalized for apnea only (hospital cohort only) ]]>
October 2012 - April 2013: RSV season 1 August 2013 - May 2014: RSV season 2 November 2014 - April 2015: RSV season 3 ]]>