NCT00874367|CompletedDMC
Early-Onset Sepsis Surveillance Study
EOS
Early-Onset Sepsis: an NICHD/CDC Surveillance Study
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EOS
Early-Onset Sepsis: an NICHD/CDC Surveillance Study
Sponsor study identifier
Secondary identifiers
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observational
615
1 country
19
Study Start
February 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Actual (reported)Study Completion
May 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2011
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2006
Date type not reportedThis date has not been verified as actual or estimated.
April 1, 2009
Actual (reported)April 2, 2009
Actual (reported)December 2009
Actual (reported)May 2011
Actual (reported)Early onset sepsis infections
Until hospital discharge
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
All live born infants \>400g birth weight delivered at NICHD Neonatal Research Network participating hospitals
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Stanford University
Palo Alto, California, 94304, United States
Yale University
New Haven, Connecticut, 06504, United States
Emory University
Atlanta, Georgia, 30303, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Stoll BJ, Hansen NI, Sanchez PJ, Faix RG, Poindexter BB, Van Meurs KP, Bizzarro MJ, Goldberg RN, Frantz ID 3rd, Hale EC, Shankaran S, Kennedy K, Carlo WA, Watterberg KL, Bell EF, Walsh MC, Schibler K, Laptook AR, Shane AL, Schrag SJ, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Early onset neonatal sepsis: the burden of group B Streptococcal and E. coli disease continues. Pediatrics. 2011 May;127(5):817-26. doi: 10.1542/peds.2010-2217. Epub 2011 Apr 25.
Samples of the isolated pathogens
Abbot R. Laptook, MD
Brown University, Women & Infants Hospital of Rhode Island
Michele C. Walsh, MD MS
Case Western Reserve University, Rainbow Babies and Children's Hospital
Ronald N. Goldberg, MD
Duke University
Barbara J. Stoll, MD
Emory University
615 participants (actual enrollment reported by the registry).
First Submitted
April 1, 2009
First Posted
April 2, 2009
Study Start
February 2006
Date type not reportedThis date has not been verified as actual or estimated.
Single-Dose Intravenous Inositol Pharmacokinetics in Preterm Infants
Prolonged exposure to maternal intrapartum antibiotics (>24 hours)
Prenatal
Placental examinations to confirm clinical diagnosis of chorioamnionitis
Prenatal
Contact the study team to confirm eligibility.
Wayne State University
Detroit, Michigan, 48201, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
University of Rochester
Rochester, New York, 14642, United States
Wake Forest University
Charlotte, North Carolina, 27157, United States
RTI International
Durham, North Carolina, 27705, United States
Duke University
Durham, North Carolina, 27710, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45267, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106, United States
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84108, United States
Brenda B. Poindexter, MD MS
Indiana University
Abhik Das, PhD
RTI International
Krisa P. Van Meurs, MD
Stanford University
Ivan D. Frantz III, MD
Tufts Medical Center
Kurt Schibler, MD
Children's Hospital Medical Center, Cincinnati
Waldemar A. Carlo, MD
University of Alabama at Birmingham
Edward F. Bell, MD
University of Iowa
Kristi L. Watterberg, MD
University of New Mexico
Pablo J. Sanchez, MD
University of Texas, Southwestern Medical Center at Dallas
Kathleen A. Kennedy, MD MPH
The University of Texas Health Science Center, Houston
Roger G. Faix, MD
University of Utah
Seetha Shankaran, MD
Wayne State University
Richard A. Ehrenkranz, MD
Yale University
Dale L. Phelps, MD
University of Rochester
T. Michael O'Shea, MD
Wake Forest University
Primary Completion
December 2009
Actual (reported)Study Completion
May 2011
Actual (reported)Last Updated
September 25, 2017
Record last verified: 2017-09
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Source: ClinicalTrials.gov.
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