Early-Onset Sepsis Surveillance Study (EOS)

This study has been completed.
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
National Center for Research Resources (NCRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
NICHD Neonatal Research Network
ClinicalTrials.gov Identifier:
NCT00874367
First received: April 1, 2009
Last updated: November 6, 2015
Last verified: October 2015
  Purpose
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.

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early-Onset Sepsis: an NICHD/CDC Surveillance Study

Resource links provided by NLM:


Further study details as provided by NICHD Neonatal Research Network:

Primary Outcome Measures:
  • Early onset sepsis infections [ Time Frame: Until hospital discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Group B streptococcal (GBS) infections [ Time Frame: Until hospital discharge ] [ Designated as safety issue: No ]
  • Symptomatic early onset sepsis infections [ Time Frame: Until hospital discharge ] [ Designated as safety issue: No ]
  • Death with early gram-negative or early gram-positive infections [ Time Frame: Until hospital discharge ] [ Designated as safety issue: Yes ]
  • Prolonged exposure to maternal intrapartum antibiotics (>24 hours) [ Time Frame: Prenatal ] [ Designated as safety issue: No ]
  • Placental examinations to confirm clinical diagnosis of chorioamnionitis [ Time Frame: Prenatal ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA
Samples of the isolated pathogens

Enrollment: 615
Study Start Date: February 2006
Study Completion Date: May 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed Description:

For more than a decade, the NICHD Neonatal Research Network (NRN) has conducted surveillance of early-onset sepsis (EOS) infections in very low birth weight (VLBW) infants, as part of its very low birth weight registry. Although overall rates of EOS have remained stable over time, the relative importance of different pathogens has changed.

In 2002 the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the Centers for Disease Control & Prevention revised their recommendations for reducing mother-to-child transmission of group B streptococcal (GBS) infections. The new guidelines recommend universal screening of pregnant women at 35 or more weeks' gestation and intrapartum antibiotics for all GBS-colonized mothers (an estimated 30% of mother-to-be in the United States). With the current widespread use of maternal antibiotics, concerns have been raised about the possible emergence of non-GBS pathogens as causes of early-onset sepsis. Several studies have reported a change in EOS pathogens, with the emergence of gram-negative and antibiotic-resistant infections, primarily among VLBW infants.

This observational study expands the NRN's prior work on infection in VLBW infants, conducting surveillance of all infants born at network centers who are diagnosed with early-onset sepsis 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. Cases will be identified by the medical care team or through research team review of patient, microbiology, or infection control/hospital epidemiology records.

Secondary analyses include:

Serotypic, phylogenetic, virulence and drug-resistance characteristics of contemporary GBS and E. Coli isolate collections will be studied.

Assessing the proportion of neonates born to mothers with chorioamnionitis who are asymptomatic at birth, but later develop signs and/or symptoms of early-onset neonatal GBS and non-GBS disease.

  Eligibility

Ages Eligible for Study:   up to 72 Hours   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All live born infants >400g birth weight delivered at NICHD Neonatal Research Network participating hospitals
Criteria

Inclusion Criteria:

  • Infants >400g birth weight

Exclusion Criteria:

  • Stillbirth or death in the delivery room
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00874367

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, California
Stanford University
Palo Alto, California, United States, 94304
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06504
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30303
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Wake Forest University
Charlotte, North Carolina, United States, 27157
RTI International
Durham, North Carolina, United States, 27705
Duke University
Durham, North Carolina, United States, 27710
United States, Ohio
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States, 45267
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
United States, Rhode Island
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75235
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
NICHD Neonatal Research Network
Centers for Disease Control and Prevention
National Center for Research Resources (NCRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Abbot R. Laptook, MD Brown University, Women & Infants Hospital of Rhode Island
Principal Investigator: Michele C. Walsh, MD MS Case Western Reserve University, Rainbow Babies and Children's Hospital
Principal Investigator: Ronald N. Goldberg, MD Duke University
Principal Investigator: Barbara J. Stoll, MD Emory University
Principal Investigator: Brenda B. Poindexter, MD MS Indiana University
Principal Investigator: Abhik Das, PhD RTI International
Principal Investigator: Krisa P. Van Meurs, MD Stanford University
Principal Investigator: Ivan D. Frantz III, MD Tufts Medical Center
Principal Investigator: Kurt Schibler, MD Children's Hospital Medical Center, Cincinnati
Principal Investigator: Waldemar A. Carlo, MD University of Alabama at Birmingham
Principal Investigator: Edward F. Bell, MD University of Iowa
Principal Investigator: Kristi L. Watterberg, MD University of New Mexico
Principal Investigator: Pablo J. Sanchez, MD University of Texas, Southwestern Medical Center at Dallas
Principal Investigator: Kathleen A. Kennedy, MD MPH The University of Texas Health Science Center, Houston
Principal Investigator: Roger G. Faix, MD University of Utah
Principal Investigator: Seetha Shankaran, MD Wayne State University
Principal Investigator: Richard A. Ehrenkranz, MD Yale University
Principal Investigator: Dale L. Phelps, MD University of Rochester
Principal Investigator: T. Michael O'Shea, MD Wake Forest University
  More Information

Additional Information:
Publications:
Responsible Party: NICHD Neonatal Research Network
ClinicalTrials.gov Identifier: NCT00874367     History of Changes
Other Study ID Numbers: NICHD-NRN-0035  U10HD021364  U10HD021373  U10HD021385  U10HD027851  U10HD027853  U10HD027856  U10HD027871  U10HD027880  U10HD027904  U10HD034216  U10HD036790  U10HD040492  U10HD040498  U10HD040521  U10HD040689  U10HD053089  U10HD053109  U10HD053119  U10HD053124  UL1RR024139  UL1RR025744  UL1RR025764  UL1RR025777  M01RR000030  M01RR000032  M01RR000039  M01RR000044  M01RR000054  M01RR000059  M01RR000064  M01RR000070  M01RR000080  M01RR000633  M01RR000750  M01RR000997  M01RR008084  M01RR006022  M01RR007122 
Study First Received: April 1, 2009
Last Updated: November 6, 2015
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by NICHD Neonatal Research Network:
NICHD Neonatal Research Network
Very Low Birth Weight (VLBW)
Extremely Low Birth Weight (ELBW)
Prematurity
Early Onset Sepsis

Additional relevant MeSH terms:
Bacterial Infections
Gram-Positive Bacterial Infections
Gram-Negative Bacterial Infections
Infection
Communicable Diseases
Sepsis
Toxemia
Birth Weight
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2016