Early Diagnosis of Candidiasis in Premature Infants
Condition: Infection; Candida; Candidiasis; Infant, Newborn; Infant, Low Birth Weight; Infant, Small for Gestational Age; Infant, Premature
MeSH terms: Candidiasis; Premature Birth; Birth Weight
Study type: Observational

Summary: 
      This observational study evaluated the performance of new lab tests in detecting candida
      species fungal infections in extremely low birth weight (ELBW) infants quickly and
      accurately. 19 NICHD Neonatal Research Network sites enrolled 1,500 infants with birth
      weights ≤1,000g; 100 of these infants later tested positive for candidiasis. Blood, urine,
      and lumbar puncture samples were collected whenever other specimens were obtained from
      participants for cultures. These samples are being tested using the new methods and compared
      with standard culture results. Surviving study subjects completed a neurodevelopmental
      evaluation at 18-22 months corrected age.
    

Detailed description: 
      Candida species are a leading cause of infectious mortality in newborns with the incidence
      rates estimated at 4-18% in extremely low birth weight (ELBW) infants. 20-30% of these
      infants are likely to die. Because candida can invade virtually all body tissues (eyes,
      brain, heart, lung, liver, spleen, urinary tract, and joints), survivors of invasive Candida
      infections are at risk of blindness, developmental delays, and the need for surgical and
      other corrective procedures.

      Time is of the essence in detecting and treating these infections, with infant mortality from
      candidiasis largely attributed to duration of time for cultures to become positive for
      Candida. Diagnosis of candidiasis is challenging - blood and urine tests are slow (taking up
      to 72 hours to complete) and inaccurate in many cases, showing negative results despite
      overwhelming disease in adults as well as children. These problems are likely made worse in
      neonates, with smaller amounts of blood available for testing and infections that often
      spread to tissues inaccessible for testing.

      This observational study is evaluating the performance of new lab tests (beta-glucan assays,
      Gas Chromatography Mass Spectrometry for D-arabinitol, and polymerase chain reaction tests)
      compared to existing culture tests in detecting candida species fungal infections in
      extremely low birth weight (ELBW) infants quickly and accurately.

      In this study, 19 NICHD Neonatal Research Network sites enrolled 1,500 infants with birth
      weights ≤1,000g by 72 hours of life; more than 100 of these infants later tested positive for
      candidiasis. In the larger cohort, whenever cultures of blood or urine were obtained, or a
      lumbar puncture was done, additional samples and clinical data were collected. These
      additional samples are being tested using the new techniques under investigation. No
      additional blood specimens were taken once participants had a positive blood culture for
      candida. Note: Test procedure reagents are being provided the Duke University laboratory by
      Cape Cod Incorporated and Rockeby; the Thrasher Research Fund is also providing support to
      the Duke University laboratory.

      Surviving study subjects completed a neurodevelopmental evaluation at 18-22 months corrected
      age to evaluate potential early risk factors with long-term outcome.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Infants with birth weights ≤1,000 grams
      
Keywords: NICHD Neonatal Research Network; Fungal Infection; Mycosis; Extremely Low Birth Weight (ELBW); Prematurity; Clinical Judgement; Polymerase chain reaction (PCR) testing; Beta-glucan assay; Mass Spectrometry; Lumbar puncture