Catheter Biofilm Microbiome in Infected Neonatal Catheters.
Condition: Catheter-associated Bloodstream Infections (CLABSI)
MeSH terms: Infections; Sepsis
Study type: Observational

Summary: 
      Percutaneously Inserted Central Catheters (PICCs) are special tubes that are inserted into
      blood vessels of premature babies (neonates) to give them nutrition and medications.
      Sometimes these tubes get infected and they need to be removed. Also, the babies need to be
      given medications to treat these infections (antibiotics). PICC infections in neonates are a
      serious problem and we need to find new ways of detecting infections early so that we can
      treat them promptly to avoid complications.

      The purpose of this study is to understand what causes tube infections in neonates and to
      develop a test to detect tube infections early to avoid complications.
    

Detailed description: 
      Catheter-associated bloodstream infections (CLABSIs) are a significant component of
      healthcare-associated infections (HAI),which are associated with significant mortality,
      morbidity and healthcare costs. Neonates are at higher risk for CLABSIs than children or
      adults and CLABSIs are seen more commonly in neonatal than pediatric or adult intensive care
      units. Neonates, who develop CLABSIs, are not only at serious risk for mortality but also
      long term neurodevelopmental impairment. CLABSIs are often caused by organisms colonizing the
      skin and the most frequently isolated organisms are CONS, S. aureus and Candida.

      The catheter biofilm microbiome, to our knowledge has not been investigated before.
      Evaluation of biofilm microbial signatures and microbial DNA load is a novel strategy that
      may permit earlier diagnosis of CLABSIs. Earlier detection may enable earlier targeted
      therapy such as antimicrobial lock solutions and may facilitate preservation of catheters in
      this vulnerable population. Catheter microbial DNA signatures or load may be useful
      biomarkers to not only predict or diagnose infections but to monitor antibiotic therapy and
      to confirm resolution of infection.

      We will study 15 percutaneously inserted central catheters (PICC) each from neonates with
      CLABSIs and those without. We will evaluate the bacterial microbiome by profiling V3-5 region
      of the 16S rDNA, by PCR and pyrosequencing. We will correlate the catheter biofilm microbiome
      with catheter tip cultures and the skin microbiome at the catheter entry site. We aim to
      identify microbial signatures that predispose to dissemination of infection from catheter
      biofilms leading to CLABSIs. Further, we will quantify microbial DNA load in blood from the
      catheters at the time of removal, by real-time PCR of the bacterial 16S rDNA.
    

Intervention name(s): Sample collection
Intervention type(s): Other
Other intervention name(s): This is an observational biospecimen collection study.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All neonates admitted to Texas Children's Hospital (TCH) NICU with indwelling catheters
        will be recruited at the time of line insertion.
      
Biospecimen description: 
      We will collect approximately 10 drops of blood from the infant for our research study. We
      will take the blood directly from the PICC tube when it is being removed. We will also take a
      skin swab from around the area where the PICC tube was placed.
    
Keywords: Neonatal Intensive Care Units (NICUs); NICUs; Neonates; CLABSI; Microbiome; DNA signature; Catheter infections