Trial Search Results
Early-Onset Sepsis an NICHD/CDC Surveillance Study
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.
Stanford is currently not accepting patients for this trial.
Lead Sponsor:
NICHD Neonatal Research Network
Collaborator: Centers for Disease Control and Prevention
Stanford Investigator(s):
Eligibility
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.
Ages Eligible for Study
N/A - 72 Hours
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Krisa P. Van Meurs, MD
650-723-5711
Not Recruiting