Early Diagnosis of Candidiasis in Premature Infants

Completed

Conditions studied: Infection, Candida, Candidiasis, Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature

In brief

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.

Key facts

Study ID

NCT00109525

Run by

NICHD Neonatal Research Network

People needed

1500

Starts

2004-03-01

Expected to finish

2009-12-01

Last updated by the study team

2019-03-22

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Infants born ≤1,000g birth weight
• Infants >72 hours old and less than 120 days old

You may not qualify if…

• Prior positive blood culture for Candida
• Evidence of congenital candidiasis
• Parents/legal guardians refuse consent

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Stanford University — Palo Alto, California, United States
• University of California at San Diego — San Diego, California, United States
• Yale University — New Haven, Connecticut, United States
• University of Miami — Miami, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Wayne State University — Detroit, Michigan, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• University of Rochester — Rochester, New York, United States
• Wake Forest University — Charlotte, North Carolina, United States
• RTI International — Durham, North Carolina, United States
• Duke University — Durham, North Carolina, United States
• Cincinnati Children's Medical Center — Cincinnati, Ohio, United States
• Case Western Reserve University, Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States
• Brown University, Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States
• University of Texas Health Science Center at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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