Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
570 participants
OBSERVATIONAL
2015-04-30
2017-12-31
Brief Summary
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Detailed Description
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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?
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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EOS infant / mother with chorio
Infant with EOS (Gram-positive or Gram-negative) and mother with Chorioamnionitis
No interventions assigned to this group
EOS infant / mother without chorio
Infant with EOS (Gram-positive or Gram-negative) and mother without Chorioamnionitis
No interventions assigned to this group
EOS Gram-neg infant / mother with chorio
Infant with Gram-negative EOS and mother with Chorioamnionitis
No interventions assigned to this group
Gram-neg infant / mother without chorio
Infant with Gram-negative EOS and mother without Chorioamnionitis
No interventions assigned to this group
Gram-pos infant / mother with chorio
Infant with Gram-positive EOS and mother with Chorioamnionitis
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
72 Hours
ALL
No
Sponsors
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Centers for Disease Control and Prevention
FED
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
NICHD Neonatal Research Network
NETWORK
Responsible Party
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Principal Investigators
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Barbara Stoll, MD
Role: STUDY_DIRECTOR
The University of Texas Health Science Center, Houston
Michele Walsh, MD
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University, Rainbow Babies and Children's Hospita
Seetha Shankaran, MD
Role: PRINCIPAL_INVESTIGATOR
Wayne State University
Abbot Laptook, MD
Role: PRINCIPAL_INVESTIGATOR
Brown University, Women & Infants Hospital of Rhode Island
Michael Cotten, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Greg Sokol, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Abhik Das, PhD
Role: PRINCIPAL_INVESTIGATOR
RTI International
Krisa Van Meurs, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Brenda Poindexter, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Waldemar Carlo, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Kristi Watterberg, MD
Role: PRINCIPAL_INVESTIGATOR
University of New Mexico
Myra Wyckoff, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas, Southwestern Medical Center at Dallas
Kathleen Kennedy, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Barbara Schmidt, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Carl D'Angio, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Pablo Sanchez, MD
Role: PRINCIPAL_INVESTIGATOR
Research Institute at Nationwide Children's Hospital
William Truog, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Mercy Hospital Kansas City
Uday Devaskar, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Bradley Yoder, MD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California - Los Angeles
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
Emory University
Atlanta, Georgia, United States
Indiana University
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
Wayne State University
Detroit, Michigan, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
University of New Mexico
Albuquerque, New Mexico, United States
University of Rochester
Rochester, New York, United States
RTI International
Durham, North Carolina, United States
Duke University
Durham, North Carolina, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
Research Institute at Nationwide Children's Hospital
Columbus, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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References
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Kilpatrick R, Greenberg R, Hansen NI, Shankaran S, Carlo WA, Cotten CM, Stoll BJ; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Use and utility of C-reactive protein (CRP) in neonatal early-onset sepsis: a secondary analysis of a prospective surveillance study. J Perinatol. 2025 Jan;45(1):139-145. doi: 10.1038/s41372-024-02064-5. Epub 2024 Aug 5.
Other Identifiers
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NICHD-NRN-0055
Identifier Type: -
Identifier Source: org_study_id
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