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: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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