Early-Onset Sepsis Surveillance Study - Full Text View

Sponsor:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators:	Centers for Disease Control and Prevention National Center for Research Resources (NCRR)
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00874367

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:

MedlinePlus related topics: Bacterial Infections Premature Babies Sepsis

U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

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:	December 2009
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.

Eligibility

Ages Eligible for Study:	up to 72 Hours
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

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
Duke University
Durham, North Carolina, United States, 27710
RTI International
Durham, North Carolina, United States, 27705
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

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

Centers for Disease Control and Prevention

National Center for Research Resources (NCRR)

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	Cincinnati Children's Medical Center
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:

NICHD Neonatal Research Network This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Barbara J. Stoll, Lead Principal Investigator, Emory University
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:	January 9, 2011
Health Authority:	United States: Federal Government United States: Institutional Review Board

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

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

Additional relevant MeSH terms:

Bacterial Infections
Birth Weight
Sepsis
Toxemia
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections

Body Weight
Signs and Symptoms
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 24, 2012