Early Diagnosis of Candidiasis in Premature Infants

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.

Conditions

• Infection
• Candida
• Candidiasis
• Infant, Newborn
• Infant, Low Birth Weight
• Infant, Small for Gestational Age
• Infant, Premature

Sponsors & Collaborators

• National Center for Research Resources (NCRR)

  collaborator NIH

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• NICHD Neonatal Research Network

  lead NETWORK

Principal Investigators

• Abbot R. Laptook, MD · Brown University, Women & Infants Hospital of Rhode Island

• Michele C. Walsh, MD MS · Case Western Reserve University, Rainbow Babies and Children's Hospital

• Ronald N. Goldberg, MD · Duke University

• Barbara J. Stoll, MD · Emory University

• Brenda B. Poindexter, MD MS · Indiana University

• Abhik Das, PhD · RTI International

• Krisa P. Van Meurs, MD · Stanford University

• Ivan D. Frantz III, MD · Tufts Medical Center

• Waldemar A. Carlo, MD · University of Alabama at Birmingham

• Neil N. Finer, MD · University of California, San Diego

• Kurt Schibler, MD · Children's Hospital Medical Center, Cincinnati

• Edward F. Bell, MD · University of Iowa

• Shahnaz Duara, MD · University of Miami

• Kristi L. Watterberg, MD · University of New Mexico

• Dale L. Phelps, MD · University of Rochester

• Kathleen A. Kennedy, MD MPH · The University of Texas Health Science Center, Houston

• Pablo J. Sanchez, MD · University of Texas, Southwestern Medical Center at Dallas

• T. Michael O'Shea, MD MPH · Wake Forest University

• Seetha Shankaran, MD · Wayne State University

• Richard A. Ehrenkranz, MD · Yale University

Eligibility

Min Age

3 Days

Max Age

120 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2004-03-31

Primary Completion

2007-07-31

Completion

2009-12-31

Countries

• United States

Study Locations