Early-Onset Sepsis an NICHD/CDC Surveillance Study

Completed

Conditions studied: Infant, Newborn, Diseases, Early Onset Neonatal Sepsis, Early-Onset Meningitis

In brief

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.

Key facts

Study ID

NCT02410486

Run by

NICHD Neonatal Research Network

People needed

570

Starts

2015-04-01

Expected to finish

2017-12-01

Last updated by the study team

2019-03-11

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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