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Early-Onset Sepsis an NICHD/CDC Surveillance Study (EOSII)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by NICHD Neonatal Research Network
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
NICHD Neonatal Research Network
ClinicalTrials.gov Identifier:
NCT02410486
First received: April 2, 2015
Last updated: December 8, 2016
Last verified: December 2016
  Purpose
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.

Condition
Infant, Newborn, Diseases
Early Onset Neonatal Sepsis
Early-Onset Meningitis

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:


Further study details as provided by NICHD Neonatal Research Network:

Primary Outcome Measures:
  • To determine current hospital-based rates of early-onset neonatal infection [ Time Frame: First 72 hours ]
  • To determine the antimicrobial susceptibility patterns of organisms associated with EOS and EOM [ Time Frame: First 72 hours ]

Secondary Outcome Measures:
  • To identify risk factors associated with EOS/EOM due to Gram-negative pathogens (case control comparison) [ Time Frame: First 72 hours ]
  • To determine the clinical signs/symptoms and laboratory abnormalities associated with EOS/EOM [ Time Frame: First 72 hours ]
  • To identify risk factors for EOS/EOM in infants born to mothers with chorioamnionitis (case control comparison) [ Time Frame: First 72 hours ]
  • To determine if term infants with EOS, identified because of maternal chorioamnionitis, can be asymptomatic at birth [ Time Frame: First 72 hours ]
  • To determine sepsis-associated mortality rates (total, GA-specific and BW-specific, pathogen-specific) for infants with EOS/EOM [ Time Frame: First 72 hours ]
  • To review changes over time in overall rates of EOS and EOM, pathogens associated with infection, risk factors for infection, clinical and laboratory abnormalities, and sepsis-associated mortality [ Time Frame: 9-11 years ]

Estimated Enrollment: 480
Study Start Date: April 2015
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
EOS infant / mother with chorio
Infant with EOS (Gram-positive or Gram-negative) and mother with Chorioamnionitis
EOS infant / mother without chorio
Infant with EOS (Gram-positive or Gram-negative) and mother without Chorioamnionitis
EOS Gram-neg infant / mother with chorio
Infant with Gram-negative EOS and mother with Chorioamnionitis
Gram-neg infant / mother without chorio
Infant with Gram-negative EOS and mother without Chorioamnionitis
Gram-pos infant / mother with chorio
Infant with Gram-positive EOS and mother with Chorioamnionitis

Detailed Description:

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?

  Eligibility

Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will include all live born infants who are at least 22 weeks GA and have a birth weight >400 grams and are delivered at NRN centers.
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02410486

Contacts
Contact: Barbara Stoll, MD Barbara.J.Stoll@uth.tmc.edu
Contact: Rosemary Higgins, MD higginsr@mail.nih.gov

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Waldemar A. Carlo, MD         
Contact: Shirley Cosby, RN         
Principal Investigator: Waldemar A. Carlo, MD         
United States, California
University of California - Los Angeles Active, not recruiting
Los Angeles, California, United States, 90025
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Krisa P. Van Meurs, MD         
Contact: M. Bethany Ball, BS CCRC         
Principal Investigator: Krisa P. Van Meurs, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30303
Contact: David Carlton, MD         
Contact: Ellen Hale, RN BS         
United States, Indiana
Indiana University Active, not recruiting
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Edward F. Bell, MD         
Contact: Karen J. Johnson, RN BSN         
Principal Investigator: Edward F. Bell, MD         
United States, Michigan
Wayne State University Active, not recruiting
Detroit, Michigan, United States, 48201
United States, Missouri
Children's Mercy Hospital Active, not recruiting
Kansas City, Missouri, United States, 64108
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Kristi L. Watterberg, MD         
Contact: Sandra Beauman, MSN, RNC-NIC         
Principal Investigator: Kristi L. Watterberg, MD         
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Carl T D'Angio, MD         
Contact: Anne Marie Scorsone         
Principal Investigator: Carl T D'Angio, MD         
United States, North Carolina
RTI International Active, not recruiting
Durham, North Carolina, United States, 27705
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: C. Michael Cotten, MD         
Principal Investigator: C. Michael Cotten, MD         
United States, Ohio
Cincinnati Children's Medical Center Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Brenda Poindexter, MD         
Contact: Cathy Grisby, BSN CCRC         
Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
Contact: Michele C. Walsh, MD MS         
Contact: Nancy S. Newman, BA RN         
Principal Investigator: Michele C. Walsh, MD MS         
Research Institute at Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Pablo Sanchez, MD         
Contact: Chris Fortney, MS, RN         
Principal Investigator: Pablo Sanchez, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Barbara Schmidt, MD         
Contact: Aasma Chaudhary, BS         
Principal Investigator: Barbara Schmidt, MD         
United States, Rhode Island
Brown University, Women & Infants Hospital of Rhode Island Recruiting
Providence, Rhode Island, United States, 02912
Contact: Abbot Laptook         
United States, Texas
University of Texas Southwestern Medical Center at Dallas Recruiting
Dallas, Texas, United States, 75235
Contact: Myra Myckoff, MD         
Principal Investigator: Myra Wyckoff, MD         
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Kathleen A. Kennedy, MD MPH         
Contact: Georgia E. McDavid, RN         
Principal Investigator: Kathleen A. Kennedy, MD MPH         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, Utah, United States, 84108
Contact: Bradley Yoder, MD         
Principal Investigator: Bradley Yoder, MD         
Sponsors and Collaborators
NICHD Neonatal Research Network
Centers for Disease Control and Prevention
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Study Director: Barbara Stoll, MD The University of Texas Health Science Center, Houston
Principal Investigator: Michele Walsh, MD Case Western Reserve University, Rainbow Babies and Children's Hospita
Principal Investigator: Seetha Shankaran, MD Wayne State University
Principal Investigator: Abbot Laptook, MD Brown University, Women & Infants Hospital of Rhode Island
Principal Investigator: Michael Cotten, MD Duke University
Principal Investigator: Greg Sokol, MD Indiana University
Principal Investigator: Abhik Das, PhD RTI International
Principal Investigator: Krisa Van Meurs, MD Stanford University
Principal Investigator: Brenda Poindexter, MD Children's Hospital Medical Center, Cincinnati
Principal Investigator: Waldemar Carlo, MD University of Alabama at Birmingham
Principal Investigator: Kristi Watterberg, MD University of New Mexico
Principal Investigator: Myra Wyckoff, MD University of Texas, Southwestern Medical Center at Dallas
Principal Investigator: Kathleen Kennedy, MD, MPH The University of Texas Health Science Center, Houston
Principal Investigator: Barbara Schmidt, MD University of Pennsylvania
Principal Investigator: Carl D'Angio, MD University of Rochester
Principal Investigator: Pablo Sanchez, MD Research Institute at Nationwide Children's Hospital
Principal Investigator: William Truog, MD Children's Mercy Hospital Kansas City
Principal Investigator: Uday Devaskar, MD University of California, Los Angeles
Principal Investigator: Bradley Yoder, MD University of Utah
  More Information

Responsible Party: NICHD Neonatal Research Network
ClinicalTrials.gov Identifier: NCT02410486     History of Changes
Other Study ID Numbers: NICHD-NRN-0055  UG1HD034216  UG1HD027904  UG1HD021364  UG1HD027853  UG1HD040689  UG1HD040492  UG1HD027851  UG1HD087229  UG1HD027856  UG1HD053109  UG1HD068284  UG1HD068278  UG1HD068244  UG1HD068263  UG1HD027880  UG1HD068270  UG1HD053089  UG1HD087226  U10HD036790 
Study First Received: April 2, 2015
Last Updated: December 8, 2016

Additional relevant MeSH terms:
Sepsis
Toxemia
Meningitis
Infant, Newborn, Diseases
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on February 17, 2017