Early Diagnosis of Candidiasis in Premature Infants
Early Diagnosis of Candidiasis in Premature Infants
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.
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.
Inclusion Criteria:

 -  Infants born ≤1,000g birth weight

 -  Infants >72 hours old and less than 120 days old

 Exclusion Criteria:

 -  Prior positive blood culture for Candida

 -  Evidence of congenital candidiasis

 -  Parents/legal guardians refuse consent