This clinical study will investigate the relationships between sequential respiratory viral infections, patterns of intestinal and respiratory bacterial colonization, and adaptive cellular immune phenotypes which are associated with increased susceptibility to respiratory infections and long term respiratory morbidity in preterm and full term infants. This is a prospective, cohort study, enrolling at a single center via two sites (URMC and URMC-affiliated Highland Hospital and Rochester General Hospital). Enrollment will be accomplished in approximately 15 - 36 months. The study will enroll 280 subjects, 150 pre-term and 130 full-term.
Age range
0 Days – 3 Years
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Calculate presence of at/near term gestation cellular immune response to mitogen and antigen specific responses to > /=1 viral pathogens isolated over 1st 2yrs CGA via lymphocyte assessment
Timeframe: 2 years CGA
Degree of adaptive immune system maturation utilizing flow cytometric analysis of lymphocytes in blood
Timeframe: From 41 weeks gestation through 3 years CGA
Degree of immune system maturation utilizing flow cytometric analysis of lymphocytes in umbilical cord blood and peripheral blood
Timeframe: From 41 weeks gestation through 3 years CGA
Etiology of symptomatic viral respiratory infections as assessed by TLDA PCR Assays of biospecimens
Timeframe: 2 years CGA
Number of respiratory tract symptomatic and asymptomatic viral infections weekly.
Timeframe: 41weeks gestation
Number of symptomatic viral respiratory infections
Timeframe: 2 years CGA
Occurrence of respiratory tract viral infections (asymptomatic and symptomatic)
Timeframe: From 37- 41 weeks gestation, through the first 1 and 2 years CGA, respectively
Patterns of respiratory and gut bacterial microbiome as they develop weekly
Timeframe: 41 weeks gestation
Pulmonary function via Respiratory Inductive Plethysmography (RIP) with Bronchodilator Response (BDR)
Timeframe: 41 weeks gestation
Rate of adaptive immune system maturation utilizing flow cytometric analysis of lymphocytes in blood
Timeframe: From 37- 41 weeks, through the first 1 and 3 years CGA
Rate of immune system maturation utilizing flow cytometric analysis of lymphocytes in umbilical cord blood and peripheral blood
Timeframe: 41 weeks gestation
Severity of illness due to viral respiratory tract infections
Timeframe: 2 years CGA
Severity of respiratory tract viral infections (asymptomatic and symptomatic) as assessed by the COAST Respiratory Symptom Scale.
Timeframe: 2 years CGA
Viral load of respiratory pathogens in the nasopharynx of infants with symptomatic RTIs
Timeframe: 2 years CGA