EOS: Early-Onset Sepsis Surveillance Study

Sponsor

NICHD Neonatal Research Network (Other)

Overall Status

Completed

CT.gov ID

NCT00874367

Collaborator

Centers for Disease Control and Prevention (U.S. Fed), National Center for Research Resources (NCRR) (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

615

Enrollment

Locations

62.9

Duration (Months)

32.4

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

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 :

Feb 1, 2006

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

May 1, 2011

Outcome Measures

Primary Outcome Measures

Early onset sepsis infections [Until hospital discharge]

Secondary Outcome Measures

Group B streptococcal (GBS) infections [Until hospital discharge]
Symptomatic early onset sepsis infections [Until hospital discharge]
Death with early gram-negative or early gram-positive infections [Until hospital discharge]
Prolonged exposure to maternal intrapartum antibiotics (>24 hours) [Prenatal]
Placental examinations to confirm clinical diagnosis of chorioamnionitis [Prenatal]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 72 Hours

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Infants >400g birth weight

Exclusion Criteria:

Stillbirth or death in the delivery room

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35233
2	Stanford University	Palo Alto	California	United States	94304
3	Yale University	New Haven	Connecticut	United States	06504
4	Emory University	Atlanta	Georgia	United States	30303
5	Indiana University	Indianapolis	Indiana	United States	46202
6	University of Iowa	Iowa City	Iowa	United States	52242
7	Tufts Medical Center	Boston	Massachusetts	United States	02111
8	Wayne State University	Detroit	Michigan	United States	48201
9	University of New Mexico	Albuquerque	New Mexico	United States	87131
10	University of Rochester	Rochester	New York	United States	14642
11	Wake Forest University	Charlotte	North Carolina	United States	27157
12	RTI International	Durham	North Carolina	United States	27705
13	Duke University	Durham	North Carolina	United States	27710
14	Cincinnati Children's Medical Center	Cincinnati	Ohio	United States	45267
15	Case Western Reserve University, Rainbow Babies and Children's Hospital	Cleveland	Ohio	United States	44106
16	Brown University, Women & Infants Hospital of Rhode Island	Providence	Rhode Island	United States	02905
17	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas	United States	75235
18	University of Texas Health Science Center at Houston	Houston	Texas	United States	77030
19	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