Skip to main content
OpenTrials
Completed

NCT Number: NCT00874367

Early-Onset Sepsis Surveillance Study

In this observational study, the NICHD Neonatal Research Network (NRN) is conducting surveillance of all infants born at NRN centers to identify all newborns who are diagnosed with early-onset sepsis (EOS) and/or meningitis. The study will: establish current hospital-based rates of EOS among term and preterm infants in the era of intrapartum antibiotic prophylaxis; monitor the organisms associated with EOS and meningitis; compare asymptomatic and symptomatic infants by gestational age and pathogen; and monitor sepsis-associated mortality rates by pathogen group.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infant, Newborn Bacterial Infections Bacterial Infections and Mycoses Female Urogenital Diseases and Pregnancy Complications Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Infant, Low Birth Weight Infant, Premature Infant, Small for Gestational Age Infections Inflammation Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Sepsis Systemic Inflammatory Response Syndrome Urogenital Diseases

Age range

Up to 72 hour

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

About this study

For more than a decade, the NICHD Neonatal Research Network (NRN) has conducted surveillance of early-onset sepsis (EOS) infections in very low birth weight (VLBW) infants, as part of its very low birth weight registry. Although overall rates of EOS have remained stable over time, the relative importance of different pathogens has changed.

In 2002 the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the Centers for Disease Control & Prevention revised their recommendations for reducing mother-to-child transmission of group B streptococcal (GBS) infections. The new guidelines recommend universal screening of pregnant women at 35 or more weeks' gestation and intrapartum antibiotics for all GBS-colonized mothers (an estimated 30% of mother-to-be in the United States). With the current widespread use of maternal antibiotics, concerns have been raised about the possible emergence of non-GBS pathogens as causes of early-onset sepsis. Several studies have reported a change in EOS pathogens, with the emergence of gram-negative and antibiotic-resistant infections, primarily among VLBW infants.

This observational study expands the NRN's prior work on infection in VLBW infants, conducting surveillance of all infants born at network centers who are diagnosed with early-onset sepsis and/or meningitis. The study will: establish current hospital-based rates of EOS among term and preterm infants in the era of intrapartum antibiotic prophylaxis; monitor the organisms associated with EOS and meningitis; compare asymptomatic and symptomatic infants by gestational age and pathogen; and monitor sepsis-associated mortality rates by pathogen group. Cases will be identified by the medical care team or through research team review of patient, microbiology, or infection control/hospital epidemiology records.

Secondary analyses include:

Serotypic, phylogenetic, virulence and drug-resistance characteristics of contemporary GBS and E. Coli isolate collections will be studied.

Assessing the proportion of neonates born to mothers with chorioamnionitis who are asymptomatic at birth, but later develop signs and/or symptoms of early-onset neonatal GBS and non-GBS disease.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants >400g birth weight

Exclusion criteria

  • Stillbirth or death in the delivery room

Treatment and study plan

Primary outcomes

  1. Early onset sepsis infections

    Time frame: Until hospital discharge

Secondary outcomes

  1. Group B streptococcal (GBS) infections

    Time frame: Until hospital discharge

  2. Symptomatic early onset sepsis infections

    Time frame: Until hospital discharge

  3. Death with early gram-negative or early gram-positive infections

    Time frame: Until hospital discharge

  4. Prolonged exposure to maternal intrapartum antibiotics (>24 hours)

    Time frame: Prenatal

  5. Placental examinations to confirm clinical diagnosis of chorioamnionitis

    Time frame: Prenatal

Sponsors and collaborators

Lead sponsor

NICHD Neonatal Research Network

Network

Collaborators

  • Centers for Disease Control and Prevention
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Center for Research Resources (NCRR)

Registry information

Official study title

Early-Onset Sepsis: an NICHD/CDC Surveillance Study

Acronym: EOS

Important dates

Study start
2006
Primary completion
2009
Study completion
2011
First posted
Apr 2, 2009
Registry last updated
Sep 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.