Impact of Respiratory Pathogens in Infants
Condition: Respiratory Tract Infection
MeSH terms: Infections; Respiratory Tract Infections
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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. This protocol does not study an agent or intervention. However,
      the bronchodilator, albuterol, a beta 2 agonist, will be administered as part of the
      Respiratory Inductive Plethysmography (RIP) pulmonary function assessments. All infants will
      remain in the study up to 3 years plus 17 weeks, depending on gestational age at birth. The
      full-term infants are expected to be typically developing newborns and generally healthy.
      Enrolled newborns will have a sample of cord blood (CB) for evaluation of lymphocyte
      phenotype and baseline neutralizing antibody titers. Maternal saliva samples will be
      collected to test exposure to environmental tobacco smoke. A nose, throat and rectal swab
      will be obtained for the assessment of the respiratory and gut microbiome and testing for
      known respiratory pathogens and pathogen discovery. Prior to hospital discharge, infants will
      have an evaluation of lymphocyte phenotype and function, and will undergo a respiratory
      assessment via RIP prior to and after a bronchodilator. Co-morbidities, familial and
      environmental risk factors for atopy, asthma and respiratory symptoms will be assessed.
      Following hospital discharge, all babies (full-term and former preterm infants) will be
      followed longitudinally through 3 years CGA as outpatients. During the first year of
      follow-up, all infants will have rectal and nose, throat swabs obtained monthly. Screening
      for symptomatic respiratory dysfunction and illnesses will also occur during the time of
      follow-up as per schedule.
    

Intervention name(s): Respiratory Inductive Plethysmography
Intervention type(s): Device
Intervention description(s): Respiratory Inductive Plethysmography (RIP) will be used to document thoracoabdominal motion, relative minute ventilation, and apnea during the minimally invasive respiratory assessments (NIRAs). Both Full and Preterm Infants will undergo a respiratory assessment via RIP prior to and after a bronchodilator (albuterol)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study subjects were enrolled from sequential preterm and full term births at the University
        of Rochester
      
Biospecimen description: 
      Urine, blood plasma, blood cells, saliva
    
Keywords: acute; adaptive cellular immune phenotypes; infants; Lymphocyte; premature; respiratory viral infections