Early-Onset Sepsis an NICHD/CDC Surveillance Study

NCT02410486 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 570

Last updated 2019-03-11

No results posted yet for this study

Summary

This prospective surveillance study will be conducted over a 2 year period to determine current rates of Early-Onset Sepsis (EOS)/ Early-Onset Meningitis (EOM), associated pathogens, antimicrobial resistance, signs and symptoms and infant outcomes.

Conditions

  • Infant, Newborn, Diseases
  • Early Onset Neonatal Sepsis
  • Early-Onset Meningitis

Sponsors & Collaborators

  • Centers for Disease Control and Prevention

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

    collaborator NIH
  • NICHD Neonatal Research Network

    lead NETWORK

Principal Investigators

  • Barbara Stoll, MD · The University of Texas Health Science Center, Houston

  • Michele Walsh, MD · Case Western Reserve University, Rainbow Babies and Children's Hospita

  • Seetha Shankaran, MD · Wayne State University

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

  • Michael Cotten, MD · Duke University

  • Greg Sokol, MD · Indiana University

  • Abhik Das, PhD · RTI International

  • Krisa Van Meurs, MD · Stanford University

  • Brenda Poindexter, MD · Children's Hospital Medical Center, Cincinnati

  • Waldemar Carlo, MD · University of Alabama at Birmingham

  • Kristi Watterberg, MD · University of New Mexico

  • Myra Wyckoff, MD · University of Texas, Southwestern Medical Center at Dallas

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

  • Barbara Schmidt, MD · University of Pennsylvania

  • Carl D'Angio, MD · University of Rochester

  • Pablo Sanchez, MD · Research Institute at Nationwide Children's Hospital

  • William Truog, MD · Children's Mercy Hospital Kansas City

  • Uday Devaskar, MD · University of California, Los Angeles

  • Bradley Yoder, MD · University of Utah

Eligibility

Max Age
72 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02410486 on ClinicalTrials.gov