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Early-Onset Sepsis an NICHD/CDC Surveillance Study (EOSII)
This study is currently recruiting participants.
Verified May 2017 by NICHD Neonatal Research Network
Sponsor:
NICHD Neonatal Research Network
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: May 23, 2017
Last verified: May 2017
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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 |
| Actual Study Start Date: | April 2015 |
| Estimated Study Completion Date: | July 2017 |
| Estimated Primary Completion Date: | July 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:
- 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).
- 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
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, 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
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 June 23, 2017