Early-Onset Sepsis Surveillance Study

Summary

In this observational study, the NICHD Neonatal Research Network (NRN) is conducting surveillance of all infants born at NRN centers to identify all newborns who are diagnosed with early-onset sepsis (EOS) and/or meningitis. The study will: establish current hospital-based rates of EOS among term and preterm infants in the era of intrapartum antibiotic prophylaxis; monitor the organisms associated with EOS and meningitis; compare asymptomatic and symptomatic infants by gestational age and pathogen; and monitor sepsis-associated mortality rates by pathogen group.

Conditions

• Infant, Newborn
• Infant, Low Birth Weight
• Infant, Small for Gestational Age
• Infant, Premature
• Sepsis
• Gram-Negative Bacterial Infections
• Gram-Positive Bacterial Infections

Sponsors & Collaborators

• Centers for Disease Control and Prevention

  collaborator FED

• 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

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

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

• Edward F. Bell, MD · University of Iowa

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

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

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

• Roger G. Faix, MD · University of Utah

• Seetha Shankaran, MD · Wayne State University

• Richard A. Ehrenkranz, MD · Yale University

• Dale L. Phelps, MD · University of Rochester

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

Eligibility

Max Age

72 Hours

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2006-02-28

Primary Completion

2009-12-31

Completion

2011-05-31

Countries

• United States

Study Locations