Early-Onset Sepsis an NICHD/CDC Surveillance Study



Status:Completed
Conditions:Infectious Disease, Hospital
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:Any
Updated:3/13/2019
Start Date:April 2015
End Date:December 2017

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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.

Neonatal pathogens other than group B Streptococcus (GBS) and resistant to beta-lactam
antibiotics have emerged as the most common etiologic agents of EOS and EOM among preterm and
term neonates and result in high mortality rates, potentially offsetting the decreased burden
of early-onset GBS disease prevented by maternal intrapartum chemoprophylaxis.

Primary Outcomes of this study:

1. To determine current hospital-based rates of early-onset neonatal infection (total,
GA-specific and BW-specific, and pathogen-specific) in term and preterm infants in the
era of maternal intrapartum antibiotic prophylaxis to prevent vertical transmission of
group B streptococcal disease. Early-onset infection comprises EOS and/or EOM and is
defined as isolation of a pathogen from blood or cerebrospinal fluid (CSF) obtained
within 72 hours of birth and provision of appropriate antibiotic treatment for 5 or more
days (or <5 days if death occurs while receiving antibiotic therapy).

2. To determine the antimicrobial susceptibility patterns of organisms associated with EOS
and EOM

The case control aspect of this study will address 2 major conundrums regarding EOS: Can we
identify risk factors for early-onset Gram-negative infections that might lead to
intervention strategies to reduce risk and can we identify infants born to mothers with
clinical chorioamnionitis who are at highest risk for early-onset sepsis and thus warrant
antibiotic treatment soon after birth?

Inclusion Criteria:

- Case Surveillance: Live born infants with gestational age of at least 22 weeks and
birth weight >400 g and <72 hours of age who are delivered at NRN hospitals and have
early-onset sepsis and meningitis defined as isolation of a pathogen from blood or CSF
obtained within 72 hours of birth and provision of appropriate antibiotic treatment
for 5 or more days (or <5 days if death occurs while receiving antibiotic therapy).

- Controls: Live born infants with gestational age of at least 22 weeks and birth weight
>400 g who are delivered at NRN hospitals and have not been evaluated for early-onset
sepsis (<72 hours of age) or if evaluated, they have sterile blood and/or CSF cultures
and were not treated with prolonged antibiotics for clinical "culture negative"
sepsis. Controls for infants with Gram-negative infection will be infants without
early-onset infection. Controls for infants born to mothers with clinical
chorioamnionitis will be infants without early-onset infection born to mothers with
clinical chorioamnionitis. Control infants will be born at the same hospital as cases,
with the same gestational age grouping as cases (22 0/7 - 28 6/7 weeks; 29 0/7 - 33
6/7 weeks; 34 0/7 - 36 6/7 weeks; and ≥ 37 weeks).

Exclusion Criteria:

- Stillbirths and infants who die in the delivery room will be excluded.

- Infants who die within 12 hours of age will be excluded if they have not been
evaluated for possible infection—ie, do not have a blood culture obtained to identify
EOS.
We found this trial at
20
sites
2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Principal Investigator: William Truog, MD
Phone: 816-234-3592
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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Kansas City, MO
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Barbara J. Stoll, MD
Phone: 404-727-5740
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Waldemar A. Carlo, MD
Phone: 205-934-4680
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
Principal Investigator: Myra Wyckoff, MD
Phone: 214-648-3923
Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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Dallas, TX
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Principal Investigator: Seetha Shankaran, MD
Phone: 313-580-4452
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Detroit, MI
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3040 East Cornwallis RoadTriangle
Durham, North Carolina 27705
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Durham, NC
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: C. Michael Cotten, MD
Phone: 919-681-0630
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Kathleen A. Kennedy, MD MPH
Phone: 713-500-6708
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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Houston, TX
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Greg Sokol, MD
Phone: 317-274-4715
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Edward F. Bell, MD
Phone: 319-356-4006
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Iowa City, IA
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Los Angeles, California 90095
310-825-4321
Principal Investigator: Uday Devaskar, MD
Phone: 310-825-9357
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Providence, RI
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Carl T D'Angio, MD
Phone: 585-273-4911
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Rochester, NY
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Bradley Yoder, MD
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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Albuquerque, New Mexico 87131
(505) 277-0111
Principal Investigator: Kristi L. Watterberg, MD
Phone: 505-272-0180
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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Albuquerque, NM
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Cincinnati, Ohio 45267
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Cincinnati, OH
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10900 Euclid Ave
Cleveland, Ohio 44106
216-368-2000
Principal Investigator: Michele C. Walsh, MD MS
Phone: 216-844-3759
Case Western Reserve Univ Continually ranked among America's best colleges, Case Western Reserve University has...
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Cleveland, OH
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Columbus, Ohio 43205
Principal Investigator: Pablo Sanchez, MD
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Columbus, OH
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Palo Alto, California 94304
Principal Investigator: Krisa P. Van Meurs, MD
Phone: 650-723-5711
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Palo Alto, CA
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Barbara Schmidt, MD
Phone: 215-662-3228
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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