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Early-Onset Sepsis Surveillance Study (EOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00874367
Recruitment Status : Completed
First Posted : April 2, 2009
Last Update Posted : September 25, 2017
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

Brief 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.

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

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.

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Study Type : Observational
Actual Enrollment : 615 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early-Onset Sepsis: an NICHD/CDC Surveillance Study
Study Start Date : February 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis




Primary Outcome Measures :
  1. Early onset sepsis infections [ Time Frame: Until hospital discharge ]

Secondary Outcome Measures :
  1. Group B streptococcal (GBS) infections [ Time Frame: Until hospital discharge ]
  2. Symptomatic early onset sepsis infections [ Time Frame: Until hospital discharge ]
  3. Death with early gram-negative or early gram-positive infections [ Time Frame: Until hospital discharge ]
  4. Prolonged exposure to maternal intrapartum antibiotics (>24 hours) [ Time Frame: Prenatal ]
  5. Placental examinations to confirm clinical diagnosis of chorioamnionitis [ Time Frame: Prenatal ]

Biospecimen Retention:   Samples Without DNA
Samples of the isolated pathogens


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00874367


Locations
Show Show 19 study locations
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
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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

Additional Information:
Publications:
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Responsible Party: NICHD Neonatal Research Network
ClinicalTrials.gov Identifier: NCT00874367    
Other Study ID Numbers: NICHD-NRN-0035
U10HD021364 ( U.S. NIH Grant/Contract )
U10HD021373 ( U.S. NIH Grant/Contract )
U10HD021385 ( U.S. NIH Grant/Contract )
U10HD027851 ( U.S. NIH Grant/Contract )
U10HD027853 ( U.S. NIH Grant/Contract )
U10HD027856 ( U.S. NIH Grant/Contract )
U10HD027871 ( U.S. NIH Grant/Contract )
U10HD027880 ( U.S. NIH Grant/Contract )
U10HD027904 ( U.S. NIH Grant/Contract )
U10HD034216 ( U.S. NIH Grant/Contract )
U10HD036790 ( U.S. NIH Grant/Contract )
U10HD040492 ( U.S. NIH Grant/Contract )
U10HD040498 ( U.S. NIH Grant/Contract )
U10HD040521 ( U.S. NIH Grant/Contract )
U10HD040689 ( U.S. NIH Grant/Contract )
U10HD053089 ( U.S. NIH Grant/Contract )
U10HD053109 ( U.S. NIH Grant/Contract )
U10HD053119 ( U.S. NIH Grant/Contract )
U10HD053124 ( U.S. NIH Grant/Contract )
UL1RR024139 ( U.S. NIH Grant/Contract )
UL1RR025744 ( U.S. NIH Grant/Contract )
UL1RR025764 ( U.S. NIH Grant/Contract )
UL1RR025777 ( U.S. NIH Grant/Contract )
M01RR000030 ( U.S. NIH Grant/Contract )
M01RR000032 ( U.S. NIH Grant/Contract )
M01RR000039 ( U.S. NIH Grant/Contract )
M01RR000044 ( U.S. NIH Grant/Contract )
M01RR000054 ( U.S. NIH Grant/Contract )
M01RR000059 ( U.S. NIH Grant/Contract )
M01RR000064 ( U.S. NIH Grant/Contract )
M01RR000070 ( U.S. NIH Grant/Contract )
M01RR000080 ( U.S. NIH Grant/Contract )
M01RR000633 ( U.S. NIH Grant/Contract )
M01RR000750 ( U.S. NIH Grant/Contract )
M01RR000997 ( U.S. NIH Grant/Contract )
M01RR008084 ( U.S. NIH Grant/Contract )
M01RR006022 ( U.S. NIH Grant/Contract )
M01RR007122 ( U.S. NIH Grant/Contract )
First Posted: April 2, 2009    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
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:
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Infection
Communicable Diseases
Sepsis
Toxemia
Bacterial Infections
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Birth Weight
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Body Weight
Signs and Symptoms