Early-Onset Sepsis an NICHD/CDC Surveillance Study (EOSII)
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| ClinicalTrials.gov Identifier: NCT02410486 |
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Recruitment Status :
Completed
First Posted : April 7, 2015
Last Update Posted : February 1, 2018
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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
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Brief Summary:
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 or disease |
|---|
| Infant, Newborn, Diseases Early Onset Neonatal Sepsis Early-Onset Meningitis |
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?
| Study Type : | Observational |
| Actual Enrollment : | 570 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Early-Onset Sepsis an NICHD/CDC Surveillance Study |
| Actual Study Start Date : | April 2015 |
| Actual Primary Completion Date : | December 2017 |
| Actual Study Completion Date : | December 2017 |
| Group/Cohort |
|---|
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EOS infant / mother with chorio
Infant with EOS (Gram-positive or Gram-negative) and mother with Chorioamnionitis
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EOS infant / mother without chorio
Infant with EOS (Gram-positive or Gram-negative) and mother without Chorioamnionitis
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EOS Gram-neg infant / mother with chorio
Infant with Gram-negative EOS and mother with Chorioamnionitis
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Gram-neg infant / mother without chorio
Infant with Gram-negative EOS and mother without Chorioamnionitis
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Gram-pos infant / mother with chorio
Infant with Gram-positive EOS and mother with Chorioamnionitis
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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 ]
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| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02410486
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35233 | |
| United States, California | |
| University of California - Los Angeles | |
| Los Angeles, California, United States, 90025 | |
| Stanford University | |
| Palo Alto, California, United States, 94304 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30303 | |
| United States, Indiana | |
| Indiana University | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| University of Iowa | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Michigan | |
| Wayne State University | |
| Detroit, Michigan, United States, 48201 | |
| United States, Missouri | |
| Children's Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
| United States, New Mexico | |
| University of New Mexico | |
| Albuquerque, New Mexico, United States, 87131 | |
| United States, New York | |
| University of Rochester | |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| RTI International | |
| Durham, North Carolina, United States, 27705 | |
| Duke University | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Cincinnati Children's Medical Center | |
| Cincinnati, Ohio, United States, 45267 | |
| Case Western Reserve University | |
| Cleveland, Ohio, United States, 44106 | |
| Research Institute at Nationwide Children's Hospital | |
| Columbus, Ohio, United States, 43205 | |
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Rhode Island | |
| Brown University, Women & Infants Hospital of Rhode Island | |
| Providence, Rhode Island, United States, 02912 | |
| United States, Texas | |
| University of Texas Southwestern Medical Center at Dallas | |
| Dallas, Texas, United States, 75235 | |
| University of Texas Health Science Center at Houston | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| University of Utah | |
| Salt Lake City, Utah, United States, 84108 | |
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 |
Additional relevant MeSH terms:
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Sepsis Toxemia Meningitis Neonatal Sepsis Infant, Newborn, Diseases Infection |
Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Central Nervous System Diseases Nervous System Diseases |