Early-Onset Sepsis Surveillance Study (EOS)
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| ClinicalTrials.gov Identifier: NCT00874367 |
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Recruitment Status :
Completed
First Posted : April 2, 2009
Last Update Posted : September 25, 2017
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| Condition or disease |
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| Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Sepsis Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections |
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.
| Study Type : | Observational |
| Actual Enrollment : | 615 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Early-Onset Sepsis: an NICHD/CDC Surveillance Study |
| Study Start Date : | February 2006 |
| Actual Primary Completion Date : | December 2009 |
| Actual Study Completion Date : | May 2011 |
- Early onset sepsis infections [ Time Frame: Until hospital discharge ]
- Group B streptococcal (GBS) infections [ Time Frame: Until hospital discharge ]
- Symptomatic early onset sepsis infections [ Time Frame: Until hospital discharge ]
- Death with early gram-negative or early gram-positive infections [ Time Frame: Until hospital discharge ]
- Prolonged exposure to maternal intrapartum antibiotics (>24 hours) [ Time Frame: Prenatal ]
- Placental examinations to confirm clinical diagnosis of chorioamnionitis [ Time Frame: Prenatal ]
Biospecimen Retention: Samples Without DNA
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| Ages Eligible for Study: | up to 72 Hours (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Infants >400g birth weight
Exclusion Criteria:
- Stillbirth or death in the delivery room
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00874367
Show 19 study locations
| Principal Investigator: | Abbot R. Laptook, MD | Brown University, Women & Infants Hospital of Rhode Island | |
| Principal Investigator: | Michele C. Walsh, MD MS | Case Western Reserve University, Rainbow Babies and Children's Hospital | |
| Principal Investigator: | Ronald N. Goldberg, MD | Duke University | |
| Principal Investigator: | Barbara J. Stoll, MD | Emory University | |
| Principal Investigator: | Brenda B. Poindexter, MD MS | Indiana University | |
| Principal Investigator: | Abhik Das, PhD | RTI International | |
| Principal Investigator: | Krisa P. Van Meurs, MD | Stanford University | |
| Principal Investigator: | Ivan D. Frantz III, MD | Tufts Medical Center | |
| Principal Investigator: | Kurt Schibler, MD | Children's Hospital Medical Center, Cincinnati | |
| Principal Investigator: | Waldemar A. Carlo, MD | University of Alabama at Birmingham | |
| Principal Investigator: | Edward F. Bell, MD | University of Iowa | |
| Principal Investigator: | Kristi L. Watterberg, MD | University of New Mexico | |
| Principal Investigator: | Pablo J. Sanchez, MD | University of Texas, Southwestern Medical Center at Dallas | |
| Principal Investigator: | Kathleen A. Kennedy, MD MPH | The University of Texas Health Science Center, Houston | |
| Principal Investigator: | Roger G. Faix, MD | University of Utah | |
| Principal Investigator: | Seetha Shankaran, MD | Wayne State University | |
| Principal Investigator: | Richard A. Ehrenkranz, MD | Yale University | |
| Principal Investigator: | Dale L. Phelps, MD | University of Rochester | |
| Principal Investigator: | T. Michael O'Shea, MD | Wake Forest University |
Publications:
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NICHD Neonatal Research Network Very Low Birth Weight (VLBW) Extremely Low Birth Weight (ELBW) Prematurity Early Onset Sepsis |
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Infections Communicable Diseases Sepsis Toxemia Bacterial Infections Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections |
Birth Weight Disease Attributes Pathologic Processes Systemic Inflammatory Response Syndrome Inflammation Body Weight Bacterial Infections and Mycoses |