Predictors of Sepsis in Ex-Preterm Infants
Condition: Sepsis; Premature Birth
MeSH terms: Sepsis; Toxemia; Premature Birth
Study type: Observational

Summary: 
      The aims of this study are to:

        -  Assess whether ex-preterm infants have a persistently immature immune system, which may
           decrease their ability to respond to infections, when they reach term-corrected
           gestational age.

        -  Examine whether clinical history, nutrition status, and microbiome composition are
           linked to the immune composition of term and ex-preterm infants and whether these
           variables can be used to predict the risk of developing sepsis or having an immunologic
           disease.
    

Detailed description: 
      Preterm infants have increased numbers of viral infections in childhood. They are also more
      likely to die from infection during the neonatal and infant periods than infants born at
      term. While studies have demonstrated that premature infants have decreased adaptive and
      innate immune responses compared with infants born at term, there has been little
      investigation into whether this impaired immunity improves and becomes similar to full term
      infants once the ex-preterm infants reach term-corrected gestational age. There have likewise
      not been studies to determine whether specific immune markers may predict the risk of
      developing sepsis. Given the immaturity of the preterm immune system and the many potential
      infectious and inflammatory insults they are exposed to during the preterm period
      (infections, poor nutrition, stress, steroid therapy), there is also a possibility that the
      relative immune deficiency experienced by preterm infants may persist into infancy.

      The goal of this study is to determine whether former preterm infants have sustained
      differences in immunity compared to age-matched controls, which would have significant
      implications for infection risk and response to vaccination. Additionally, this study hopes
      to examine whether certain immune system abnormalities make certain babies more likely to
      have a serious infection. The present study will assess composition and function of T and B
      cell compartments in preterm and former preterm infants.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Both term and preterm infants will be included in the study.
      
Biospecimen description: 
      Subjects will have up to 0.5 ml of blood collected as a sample within the first 1-2 weeks
      after the subject is enrolled. After that any discard blood samples which have been obtained
      as part of clinically requested blood draws will be obtained from the Core Laboratory at the
      institution.

      If there are no discard samples available an additional 0.5mL blood sample and a stool sample
      will be collected on a monthly basis until the subject is discharged from the hospital or up
      to a maximum of 6 months.

      If the investigators learn information that might be important for the subject's family the
      investigators may be able to have these results confirmed by a CLIA-certified clinical
      laboratory that is allowed to provide results.
    
Keywords: Sepsis; Prematurity